Pharsight

1. Adlarity patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11679086	CORIUM	Systems comprising a composite backing and methods for long term transdermal administration	May, 2037 (12 years from now)
US11103463	CORIUM	Methods for treating alzheimer's disease with donepezil transdermal system	Jul, 2037 (12 years from now)
US9993466	CORIUM	Donepezil transdermal delivery system	Jul, 2037 (12 years from now)
US10300025	CORIUM	Donepezil transdermal delivery system	Jul, 2037 (12 years from now)
US10016372	CORIUM	Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery	Jul, 2037 (12 years from now)
US10307379	CORIUM	Donepezil transdermal delivery system	Jul, 2037 (12 years from now)
US11648214	CORIUM	Systems and methods for long term transdermal administration	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 11, 2025

Drugs and Companies using DONEPEZIL HYDROCHLORIDE ingredient

Market Authorisation Date: 11 March, 2022

Treatment: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the alzheimer's type

Dosage: SYSTEM

Strength	Dosage	Availability
5MG/DAY	SYSTEM	Prescription
10MG/DAY	SYSTEM	Prescription

ADLARITY family patents

2. Airduo Digihaler patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10569034 (Pediatric)	TEVA PHARM	Compliance monitoring module for a breath-actuated inhaler	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-61)	Jul 09, 2024
Pediatric Exclusivity(PED)	Jan 09, 2025

Drugs and Companies using FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE ingredient

Market Authorisation Date: 12 July, 2019

Treatment: NA

Dosage: POWDER

Strength	Dosage	Availability
0.055MG/INH;EQ 0.014MG BASE/INH	POWDER	Discontinued
0.113MG/INH;EQ 0.014MG BASE/INH	POWDER	Discontinued
0.232MG/INH;EQ 0.014MG BASE/INH	POWDER	Discontinued

AIRDUO DIGIHALER family patents

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3. Akeega patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11207311	JANSSEN BIOTECH	Method of treating prostate cancer	Jul, 2037 (12 years from now)
US11992486	JANSSEN BIOTECH	Methods of treating prostate cancer	Jul, 2037 (12 years from now)
US11986468	JANSSEN BIOTECH	Methods of treating prostate cancer	Jul, 2037 (12 years from now)
US11986469	JANSSEN BIOTECH	Methods of treating prostate cancer	Jul, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Aug 11, 2026

Drugs and Companies using ABIRATERONE ACETATE; NIRAPARIB TOSYLATE ingredient

Market Authorisation Date: 11 August, 2023

Treatment: A method for treating metastatic castration-resistant prostate cancer (mcrpc), wherein the cancer is associated with a deleterious brca-mutation

Dosage: TABLET

Strength	Dosage	Availability
500MG;EQ 50MG BASE	TABLET	Prescription
500MG;EQ 100MG BASE	TABLET	Prescription

AKEEGA family patents

4. Akynzeo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11529362	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (12 years from now)
US10624911	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 19, 2023

Drugs and Companies using FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE ingredient

NCE-1 date: 19 April, 2022

Market Authorisation Date: 19 April, 2018

Treatment: NA

Dosage: POWDER; SOLUTION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
235 mg/0.25 mg per 20 mL	19 Apr, 2022	1		02 Jun, 2037

Strength	Dosage	Availability
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER	Discontinued
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION	Prescription

AKYNZEO family patents

5. Amzeeq patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10849847	JOURNEY	Compositions and methods for treating rosacea and acne	Sep, 2037 (12 years from now)
US10398641	JOURNEY	Compositions and methods for treating rosacea and acne	Sep, 2037 (12 years from now)

Drugs and Companies using MINOCYCLINE HYDROCHLORIDE ingredient

Market Authorisation Date: 18 October, 2019

Treatment: Treatment of non-nodular acne vulgaris

Dosage: AEROSOL, FOAM

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.04	11 May, 2021	1		08 Sep, 2037

Strength	Dosage	Availability
EQ 4% BASE	AEROSOL, FOAM	Prescription

AMZEEQ family patents

6. Armonair Digihaler patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10569034 (Pediatric)	TEVA PHARM	Compliance monitoring module for a breath-actuated inhaler	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Jul 09, 2024
Pediatric Exclusivity(PED)	Jan 09, 2025

Drugs and Companies using FLUTICASONE PROPIONATE ingredient

Market Authorisation Date: 08 April, 2022

Treatment: NA

Dosage: POWDER

Strength	Dosage	Availability
0.055MG/INH	POWDER	Discontinued
0.03MG/INH	POWDER	Discontinued
0.113MG/INH	POWDER	Discontinued
0.232MG/INH	POWDER	Discontinued

ARMONAIR DIGIHALER family patents

7. Atorvaliq patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11369567	CMP DEV LLC	Aqueous suspension suitable for oral administration	Jun, 2037 (12 years from now)
US11925704	CMP DEV LLC	Aqueous suspension suitable for oral administration	Jun, 2037 (12 years from now)
US11654106	CMP DEV LLC	Aqueous suspension suitable for oral administration	Jun, 2037 (12 years from now)

Drugs and Companies using ATORVASTATIN CALCIUM ingredient

Market Authorisation Date: 01 February, 2023

Treatment: Method for lowering cholesterol level in a human; As an adjunct to other low-density lipoprotein cholesterol (ldl-c) lowering therapies, or alone if such treatments are unavailable, to reduce ldl-c in...

Dosage: SUSPENSION

Strength	Dosage	Availability
20MG/5ML	SUSPENSION	Prescription

ATORVALIQ family patents

8. Auvi-q patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10688244	KALEO INC	Medicament delivery device and methods for delivering drugs to infants and children	Dec, 2037 (13 years from now)
US10842938	KALEO INC	Medicament delivery device and methods for delivering drugs to infants and children	Dec, 2037 (13 years from now)
US11771830	KALEO INC	Medicament delivery device and methods for delivering drugs to infants and children	Dec, 2037 (13 years from now)

Drugs and Companies using EPINEPHRINE ingredient

Market Authorisation Date: 17 November, 2017

Treatment: Method of treating an allergic reaction using an auto-injector

Dosage: SOLUTION

Strength	Dosage	Availability
EQ 0.15MG/DELIVERY	SOLUTION	Prescription
EQ 0.1MG/DELIVERY	SOLUTION	Prescription

AUVI-Q family patents

9. Azstarys patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10584112	COMMAVE THERAP	Methylphenidate-prodrugs, processes of making and using the same	Dec, 2037 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10759778	COMMAVE THERAP	Methylphenidate-prodrugs, processes of making and using the same	Dec, 2037 (13 years from now)
US10584113	COMMAVE THERAP	Methylphenidate-prodrugs, processes of making and using the same	Dec, 2037 (13 years from now)
US10954213	COMMAVE THERAP	Compositions comprising methylphenidate-prodrugs, processes of making and using the same	Dec, 2037 (13 years from now)
US10858341	COMMAVE THERAP	Compositions comprising methylphenidate-prodrugs, processes of making and using the same	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 07, 2026

Drugs and Companies using DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE ingredient

NCE-1 date: 07 May, 2025

Market Authorisation Date: 07 May, 2021

Treatment: Treatment of attention-deficit hyperactivity disorder (adhd) with serdexmethylphenidate and dexmethylphenidate

Dosage: CAPSULE

Strength	Dosage	Availability
EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE	Prescription
EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE	Prescription
EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE	Prescription

AZSTARYS family patents

10. Bludigo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10927258	PROVEPHARM SAS	Process for the preparation of Indigotindisulfonate sodium (indigo carmine)	Dec, 2037 (13 years from now)
US11499050	PROVEPHARM SAS	Process for the preparation of indigotindisulfonate sodium (indigo carmine)	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 08, 2027

Drugs and Companies using INDIGOTINDISULFONATE SODIUM ingredient

NCE-1 date: 08 July, 2026

Market Authorisation Date: 08 July, 2022

Treatment: NA

Dosage: SOLUTION

Strength	Dosage	Availability
40MG/5ML (8MG/ML)	SOLUTION	Prescription

BLUDIGO family patents

11. Brukinsa patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11851437	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (12 years from now)
US10927117	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11970500	BEIGENE	Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (12 years from now)
US11884674	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (12 years from now)
US11591340	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-871)	Aug 31, 2024
New Indication(I-874)	Sep 14, 2024
New Chemical Entity Exclusivity(NCE)	Nov 14, 2024
New Indication(I-817)	Jan 19, 2026
Orphan Drug Exclusivity(ODE-276)	Nov 14, 2026
New Indication(I-936)	Mar 07, 2027
Orphan Drug Exclusivity(ODE-371)	Aug 31, 2028
Orphan Drug Exclusivity(ODE-370)	Sep 14, 2028
Orphan Drug Exclusivity(ODE-274)	Jan 19, 2030
Orphan Drug Exclusivity(ODE-467)	Mar 07, 2031

Drugs and Companies using ZANUBRUTINIB ingredient

NCE-1 date: 15 November, 2023

Market Authorisation Date: 14 November, 2019

Treatment: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with relapsed or refractory follicular lymphoma (fl), in combination wit...

Dosage: CAPSULE

Strength	Dosage	Availability
80MG	CAPSULE	Prescription

BRUKINSA family patents

12. Cabometyx patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11141413	EXELIXIS INC	Method of treating renal cell carcinoma using N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-N′-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2S)-hydroxybutanedioate	Apr, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 29, 2017
New Product(NP)	Apr 25, 2019
New Indication(I-760)	Dec 19, 2020
New Indication(I-792)	Jan 14, 2022
New Indication(I-854)	Jan 22, 2024
New Indication(I-873)	Sep 17, 2024
Orphan Drug Exclusivity(ODE-227)	Jan 14, 2026
Orphan Drug Exclusivity(ODE-375)	Sep 17, 2028

Drugs and Companies using CABOZANTINIB S-MALATE ingredient

NCE-1 date: 29 November, 2016

Market Authorisation Date: 25 April, 2016

Treatment: Treatment of advanced renal cell carcinoma (rcc) in patients who have received prior anti-angiogenic therapy

Dosage: TABLET

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
20 mg, 40 mg and 60 mg	16 Aug, 2019	1		09 Jul, 2033

Strength	Dosage	Availability
EQ 60MG BASE	TABLET	Prescription
EQ 20MG BASE	TABLET	Prescription
EQ 40MG BASE	TABLET	Prescription

CABOMETYX family patents

13. Calcium Gluconate In Sodium Chloride patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10130646	HQ SPCLT PHARMA	Calcium gluconate solutions in flexible containers	Jul, 2037 (12 years from now)
US10342813	HQ SPCLT PHARMA	Calcium gluconate solutions in flexible containers	Jul, 2037 (12 years from now)

Drugs and Companies using CALCIUM GLUCONATE ingredient

Market Authorisation Date: 29 October, 2018

Treatment: NA

Dosage: SOLUTION

Strength	Dosage	Availability
1GM/50ML (20MG/ML)	SOLUTION	Prescription
2GM/100ML (20MG/ML)	SOLUTION	Prescription
1GM/100ML (10MG/ML)	SOLUTION	Prescription

CALCIUM GLUCONATE IN SODIUM CHLORIDE family patents

14. Cequa patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10918694	SUN PHARM	Topical cyclosporine-containing formulations and uses thereof	Feb, 2037 (12 years from now)
US11951153	SUN PHARM	Topical cyclosporine-containing formulations and uses thereof	Feb, 2037 (12 years from now)

Drugs and Companies using CYCLOSPORINE ingredient

Market Authorisation Date: 14 August, 2018

Treatment: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Dosage: SOLUTION

Strength	Dosage	Availability
0.09%	SOLUTION	Prescription

CEQUA family patents

15. Definity patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11266750	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11925695	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US10583208	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11529431	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11857646	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US9789210	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US10588988	LANTHEUS MEDCL	Methods and devices for preparation of ultrasound contrast agents	May, 2037 (12 years from now)

Drugs and Companies using PERFLUTREN ingredient

Market Authorisation Date: 31 July, 2001

Treatment: Method of using the drug substance/drug product for ultrasound imaging

Dosage: INJECTABLE

Strength	Dosage	Availability
13.04MG/2ML (6.52MG/ML)	INJECTABLE	Prescription

DEFINITY family patents

16. Definity Rt patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11925695	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11529431	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US9789210	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11266750	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US11857646	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US10583208	LANTHEUS MEDCL	Methods for making ultrasound contrast agents	Mar, 2037 (12 years from now)
US10588988	LANTHEUS MEDCL	Methods and devices for preparation of ultrasound contrast agents	May, 2037 (12 years from now)

Drugs and Companies using PERFLUTREN ingredient

Market Authorisation Date: 31 July, 2001

Treatment: Method of using the drug substance/drug product for ultrasound imaging

Dosage: INJECTABLE

Strength	Dosage	Availability
13.04MG/2ML (6.52MG/ML)	INJECTABLE	Prescription

DEFINITY RT family patents

17. Dextenza patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11458041	OCULAR THERAPEUTIX	Punctal plug and bioadhesives	Nov, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 30, 2021
New Indication(I-800)	Jun 20, 2022
New Indication(I-876)	Oct 07, 2024

Drugs and Companies using DEXAMETHASONE ingredient

Market Authorisation Date: 30 November, 2018

Treatment: Treatment of ocular inflammation and pain following ophthalmic surgery

Dosage: INSERT

Strength	Dosage	Availability
0.4MG	INSERT	Prescription

DEXTENZA family patents

18. Drizalma Sprinkle patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10413525	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US11202772	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US10959982	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)
US9839626	SUN PHARM	Duloxetine sprinkles	Apr, 2037 (12 years from now)

Drugs and Companies using DULOXETINE HYDROCHLORIDE ingredient

Market Authorisation Date: 19 July, 2019

Treatment: NA

Dosage: CAPSULE, DELAYED REL PELLETS

Strength	Dosage	Availability
EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS	Prescription
EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS	Prescription
EQ 60MG BASE	CAPSULE, DELAYED REL PELLETS	Prescription
EQ 30MG BASE	CAPSULE, DELAYED REL PELLETS	Prescription

DRIZALMA SPRINKLE family patents

19. Edurant Ped patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11065198	JANSSEN PRODS	Dispersible compositions	Oct, 2037 (12 years from now)

Drugs and Companies using RILPIVIRINE HYDROCHLORIDE ingredient

Market Authorisation Date: 15 March, 2024

Treatment: NA

Dosage: TABLET, FOR SUSPENSION

EDURANT PED family patents

20. Entresto Sprinkle patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10722471	NOVARTIS	Galenic formulations of organic compounds	Feb, 2037 (12 years from now)

Drugs and Companies using SACUBITRIL; VALSARTAN ingredient

Market Authorisation Date: 12 April, 2024

Treatment: Treatment of heart failure with oral pellets

Dosage: CAPSULE, PELLETS

ENTRESTO SPRINKLE family patents

21. Esbriet patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10188637	GENENTECH INC	Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 15, 2019
Orphan Drug Exclusivity(ODE)	Oct 15, 2021
Orphan Drug Exclusivity(ODE-77)	Oct 15, 2021

Drugs and Companies using PIRFENIDONE ingredient

NCE-1 date: 15 October, 2018

Market Authorisation Date: 11 January, 2017

Treatment: NA

Dosage: TABLET

ESBRIET family patents

22. Evekeo Odt patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11160772	AZURITY	Oral amphetamine composition	Mar, 2037 (12 years from now)
US10441554	AZURITY	Oral amphetamine composition	Mar, 2037 (12 years from now)
US11896562	AZURITY	Oral amphetamine composition	Mar, 2037 (12 years from now)

Drugs and Companies using AMPHETAMINE SULFATE ingredient

Market Authorisation Date: 16 April, 2021

Treatment: Treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients

Dosage: TABLET, ORALLY DISINTEGRATING

EVEKEO ODT family patents

23. Fintepla patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10947183 (Pediatric)	UCB INC	Fenfluramine compositions and methods of preparing the same	Jun, 2037 (12 years from now)
US11040018	UCB INC	Formulation for inhibiting formation of 5-HT2B agonists and methods of using same	Aug, 2037 (12 years from now)
US11786487	UCB INC	Formulation for inhibiting formation of 5-HT2B agonists and methods of using same	Aug, 2037 (12 years from now)
US10603290	UCB INC	Formulation for inhibiting formation of 5-HT2B agonists and methods of using same	Aug, 2037 (12 years from now)
US11759440	UCB INC	Formulation for inhibiting formation of 5-HT2B agonists and methods of using same	Aug, 2037 (12 years from now)
US11406606	UCB INC	Formulation for inhibiting formation of 5-HT2B agonists and methods of using same	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jun 25, 2023
New Indication(I-887)	Mar 25, 2025
Orphan Drug Exclusivity(ODE-312)	Jun 25, 2027
Orphan Drug Exclusivity(ODE-393)	Mar 25, 2029
Pediatric Exclusivity(PED)	Sep 25, 2029

Drugs and Companies using FENFLURAMINE HYDROCHLORIDE ingredient

Market Authorisation Date: 25 June, 2020

Treatment: Use in combination with cannabidiol for the treatment of seizures associated with lennox-gastaut syndrome; Method of treating seizures in a patient by administering a liquid formulation of fenfluramin...

Dosage: SOLUTION

FINTEPLA family patents

24. Firdapse patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10626088	CATALYST PHARMS	Determining degradation of 3,4-diaminopyridine	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 28, 2023
New Patient Population(NPP)	Sep 29, 2025
Orphan Drug Exclusivity(ODE-223)	Nov 28, 2025

Drugs and Companies using AMIFAMPRIDINE PHOSPHATE ingredient

NCE-1 date: 28 November, 2022

Market Authorisation Date: 28 November, 2018

Treatment: NA

Dosage: TABLET

FIRDAPSE family patents

25. Fleqsuvy patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11446246	AZURITY	Suspensions and diluents for metronidazole and baclofen	Sep, 2037 (12 years from now)
US11324696	AZURITY	Suspensions and diluents for metronidazole and baclofen	Sep, 2037 (12 years from now)

Drugs and Companies using BACLOFEN ingredient

Market Authorisation Date: 04 February, 2022

Treatment: Indicated for the treatment of spasticity resulting from multiple sclerosis

Dosage: SUSPENSION

FLEQSUVY family patents

26. Fluorescein Sodium And Benoxinate Hydrochloride patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10632197	BAUSCH LOMB IRELAND	Fluorescein and benoxinate compositions	Nov, 2037 (13 years from now)
US10842872	BAUSCH LOMB IRELAND	Fluorescein and benoxinate compositions	Nov, 2037 (13 years from now)
US10293047	BAUSCH LOMB IRELAND	Fluorescein and benoxinate compositions	Nov, 2037 (13 years from now)

Drugs and Companies using BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM ingredient

Market Authorisation Date: 09 March, 2020

Treatment: Ocular examination, intraocular pressure measurement, or removal of foreign bodies or sutures, in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic ane...

Dosage: SOLUTION/DROPS

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE family patents

27. Galafold patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11234972	AMICUS THERAP US	Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene	Mar, 2037 (12 years from now)
US10076514	AMICUS THERAP US	Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 10, 2023
Orphan Drug Exclusivity(ODE-205)	Aug 10, 2025

Drugs and Companies using MIGALASTAT HYDROCHLORIDE ingredient

NCE-1 date: 10 August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: The treatment of fabry patients

Dosage: CAPSULE

GALAFOLD family patents

28. Giapreza patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11219662	LA JOLLA PHARMA	Methods for treating hypotension in a patient that has received an ACE inhibitor by administering angiotensin II	Jan, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 21, 2022

Drugs and Companies using ANGIOTENSIN II ACETATE ingredient

NCE-1 date: 21 December, 2021

Market Authorisation Date: 23 December, 2021

Treatment: Treating hypotension with angiotensin ii in a patient receiving an angiotensin converting enzyme inhibitor

Dosage: SOLUTION

GIAPREZA family patents

29. Gloperba patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10226423	SCILEX PHARMS	Colchicine drug-to-drug interactions	Dec, 2037 (13 years from now)

Drugs and Companies using COLCHICINE ingredient

Market Authorisation Date: 30 January, 2019

Treatment: NA

Dosage: SOLUTION

GLOPERBA family patents

30. Goprelto patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10973811	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10933060	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10231961	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10149843	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10987347	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10420760	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10857095	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10894012	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US11040032	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10413505	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US9867815	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10016407	NODEN PHARMA	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 14, 2022

Drugs and Companies using COCAINE HYDROCHLORIDE ingredient

NCE-1 date: 14 December, 2021

Market Authorisation Date: 14 December, 2017

Treatment: Method of administering a local anesthetic to the mucous membranes in patients with renal impairment; Method for the induction of local anesthesia of the mucous membranes; Method for the induction of ...

Dosage: SOLUTION

GOPRELTO family patents

31. Hemady patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11304961	DEXCEL	Compositions comprising dexamethasone	Dec, 2037 (13 years from now)
US10537585	DEXCEL	Compositions comprising dexamethasone	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-271)	Oct 03, 2026

Drugs and Companies using DEXAMETHASONE ingredient

Market Authorisation Date: 03 October, 2019

Treatment: A method of treating adults with multiple myeloma using dexamethasone in combination with an anti-myeloma product

Dosage: TABLET

HEMADY family patents

32. Igalmi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11786508	BIOXCEL	Use of sublingual dexmedetomidine for the treatment of agitation	Dec, 2037 (13 years from now)
US11839604	BIOXCEL	Use of sublingual dexmedetomidine for the treatment of agitation	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 05, 2025

Drugs and Companies using DEXMEDETOMIDINE HYDROCHLORIDE ingredient

Market Authorisation Date: 05 April, 2022

Treatment: Acute treatment of agitation associated with schizophrenia by sublingual or buccal administration; Acute treatment of agitation associated with bipolar i or ii disorder by sublingual or buccal adminis...

Dosage: FILM

IGALMI family patents

33. Ingrezza patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10857137	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10857148	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10993941	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10952997	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10912771	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10874648	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US11439629	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US11040029	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 11, 2022
New Indication(I-925)	Aug 18, 2026
Orphan Drug Exclusivity(ODE-440)	Aug 18, 2030

Drugs and Companies using VALBENAZINE TOSYLATE ingredient

NCE-1 date: 11 April, 2021

Market Authorisation Date: 11 April, 2017

Treatment: Treatment of tardive dyskinesia; Method of treating tardive dyskinesia while avoiding concomitant use of a strong cyp3a4 inducer; A method of treating huntington's chorea

Dosage: CAPSULE

INGREZZA family patents

34. Ingrezza Sprinkle patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10857137	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10857148	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10874648	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10912771	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10952997	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US10993941	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US11040029	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)
US11439629	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-925)	Aug 18, 2026

Drugs and Companies using VALBENAZINE TOSYLATE ingredient

Market Authorisation Date: 30 April, 2024

Treatment: Treatment of tardive dyskinesia; Method of administering valbenazine while avoiding concomitant use of a strong cyp3a4 inducer; A method of treating huntington's chorea

Dosage: CAPSULE

INGREZZA SPRINKLE family patents

35. Inlyta patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10869924	PF PRISM CV	PD-L1 antagonist combination treatments	Jan, 2037 (12 years from now)
US10869924 (Pediatric)	PF PRISM CV	PD-L1 antagonist combination treatments	Jul, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 27, 2017

Drugs and Companies using AXITINIB ingredient

NCE-1 date: 28 January, 2016

Market Authorisation Date: 27 January, 2012

Treatment: Axitinib in combination with avelumab for the first-line treatment of patients with advanced renal cell carcinoma

Dosage: TABLET

INLYTA family patents

36. Iqirvo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11857523	IPSEN	Methods of treatment of cholestatic diseases	Mar, 2037 (12 years from now)
US11331292	IPSEN	Methods of treatment of cholestatic diseases	Mar, 2037 (12 years from now)
US11850223	IPSEN	Methods of treatment of cholestatic diseases	Mar, 2037 (12 years from now)
US11185519	IPSEN	Methods of treatment of cholestatic diseases	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 10, 2029
Orphan Drug Exclusivity(ODE-486)	Jun 10, 2031

Drugs and Companies using ELAFIBRANOR ingredient

NCE-1 date: 10 June, 2028

Market Authorisation Date: 10 June, 2024

Treatment: Treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults who have had an inadequate response to udca, or as monotherapy in patients unable to tolerate u...

Dosage: TABLET

IQIRVO family patents

37. Katerzia patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11471409	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US11364230	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US11701326	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US11484498	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US12053461	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US10894039	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US11918685	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US10959991	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US10952998	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)
US10695329	AZURITY	Amlodipine formulations	Oct, 2037 (12 years from now)

Drugs and Companies using AMLODIPINE BENZOATE ingredient

Market Authorisation Date: 08 July, 2019

Treatment: A method of treating hypertension; Method of treating hypertension; Angina

Dosage: SUSPENSION

KATERZIA family patents

38. Korlym patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10151763	CORCEPT THERAP	Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome	Jan, 2037 (12 years from now)
US11969435	CORCEPT THERAP	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors	Jun, 2037 (12 years from now)
US12097210	CORCEPT THERAP	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors	Jun, 2037 (12 years from now)
US10195214	CORCEPT THERAP	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors	Jun, 2037 (12 years from now)
US10842800	CORCEPT THERAP	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors	Jun, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Feb 17, 2015
Orphan Drug Exclusivity(ODE)	Feb 17, 2019
Orphan Drug Exclusivity(ODE-22)	Feb 17, 2019

Drugs and Companies using MIFEPRISTONE ingredient

Market Authorisation Date: 17 February, 2012

Treatment: Treating cushing's syndrome

Dosage: TABLET

KORLYM family patents

39. Krazati patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10689377	BRISTOL	KRas G12C inhibitors	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 12, 2027
Orphan Drug Exclusivity(ODE-352)	Dec 12, 2029

Drugs and Companies using ADAGRASIB ingredient

NCE-1 date: 12 December, 2026

Market Authorisation Date: 12 December, 2022

Treatment: Treatment, in combination with cetuximab, of adult patients with kras g12c-muted locally advanced or metastatic colorectal cancer, per fda approved test, where prior treatment with fluoropyrimidine-, ...

Dosage: TABLET

KRAZATI family patents

40. Leqselvi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US12076323	SUN PHARM INDS INC	Treatment of hair loss disorders with deuterated JAK inhibitors	May, 2037 (12 years from now)
US10561659	SUN PHARM INDS INC	Treatment of hair loss disorders with deuterated JAK inhibitors	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 25, 2029

Drugs and Companies using DEURUXOLITINIB PHOSPHATE ingredient

NCE-1 date: 25 July, 2028

Market Authorisation Date: 25 July, 2024

Treatment: Treatment of adult patients with alopecia areata

Dosage: TABLET

LEQSELVI family patents

41. Lexette patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10857159 (Pediatric)	MAYNE PHARMA	Halobetasol foam composition and method of use thereof	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	May 24, 2021
New Patient Population(NPP)	Aug 18, 2024

Drugs and Companies using HALOBETASOL PROPIONATE ingredient

Market Authorisation Date: 24 May, 2018

Treatment: NA

Dosage: AEROSOL, FOAM

LEXETTE family patents

42. Lonsurf patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10456399	TAIHO ONCOLOGY	Method for treating cancer patients with severe renal impairment	Feb, 2037 (12 years from now)
US10960004	TAIHO ONCOLOGY	Method for treating cancer patients with severe renal impairment	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 22, 2020
New Indication(I-794)	Feb 22, 2022
Orphan Drug Exclusivity(ODE-229)	Feb 22, 2026

Drugs and Companies using TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE ingredient

NCE-1 date: 23 September, 2019

Market Authorisation Date: 22 September, 2015

Treatment: Treatment of metastatic colorectal cancer alone or with bevacizumab in severely renally impaired patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan therapy, an anti-vegf b...

Dosage: TABLET

LONSURF family patents

43. Lumryz patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11000498	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11602513	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11602512	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11400065	AVADEL CNS	Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state	Jul, 2037 (12 years from now)
US11986451	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US10952986	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11826335	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11896572	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11839597	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11766418	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11065224	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US10272062	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11504347	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US10973795	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US11052061	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)
US10736866	AVADEL CNS	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics	Jul, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 01, 2026
Orphan Drug Exclusivity(ODE-431)	May 01, 2030
Orphan Drug Exclusivity(ODE-494)	Oct 16, 2031

Drugs and Companies using SODIUM OXYBATE ingredient

Market Authorisation Date: 01 May, 2023

Treatment: Treatment of narcolepsy using a dose proportional, oral pharmaceutical composition comprising gamma-hydroxybutyrate once daily; Treatment of narcolepsy-related cataplexy or excessive daytime sleepines...

Dosage: FOR SUSPENSION, EXTENDED RELEASE

LUMRYZ family patents

44. Lupkynis patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10286036	AURINIA	Protocol for treatment of lupus nephritis	Dec, 2037 (13 years from now)
US11622991	AURINIA	Protocol for treatment of lupus nephritis	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 22, 2026

Drugs and Companies using VOCLOSPORIN ingredient

NCE-1 date: 22 January, 2025

Market Authorisation Date: 22 January, 2021

Treatment: Treatment of patients with active lupus nephritis

Dosage: CAPSULE

LUPKYNIS family patents

45. Miebo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10507132	BAUSCH AND LOMB INC	Topical administration method	Jun, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 18, 2028

Drugs and Companies using PERFLUOROHEXYLOCTANE ingredient

NCE-1 date: 19 May, 2027

Market Authorisation Date: 18 May, 2023

Treatment: Treatment of the signs and symptoms of dry eye disease (ded)

Dosage: SOLUTION/DROPS

MIEBO family patents

46. Myfembree patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11957684	SUMITOMO PHARMA	Treatment of heavy menstrual bleeding associated with uterine fibroids	Sep, 2037 (12 years from now)
US11033551	SUMITOMO PHARMA	Methods of treating uterine fibroids	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 26, 2024
New Indication(I-898)	Aug 05, 2025
New Chemical Entity Exclusivity(NCE)	Dec 18, 2025
M(M-289)	Jan 27, 2026

Drugs and Companies using ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX ingredient

NCE-1 date: 18 December, 2024

Market Authorisation Date: 26 May, 2021

Treatment: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women

Dosage: TABLET

MYFEMBREE family patents

47. Numbrino patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10231961	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US11040032	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10973811	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10894012	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10857095	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10420760	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10413505	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10149843	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10016407	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US9867815	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)
US10933060	OMNIVIUM PHARMS	Pharmaceutical compositions and methods of using the same	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 14, 2022
New Product(NP)	Jan 10, 2023

Drugs and Companies using COCAINE HYDROCHLORIDE ingredient

NCE-1 date: 14 December, 2021

Market Authorisation Date: 10 January, 2020

Treatment: A method for treating a subject with uveal melanoma with unresectable hepatic metastases; Method for the induction of local anesthesia of the mucous membranes; Method for the induction of local anesth...

Dosage: SOLUTION

NUMBRINO family patents

48. Nuplazid patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10953000	ACADIA PHARMS INC	Combination of pimavanserin and cytochrome P450 modulators	Mar, 2037 (12 years from now)
US10517860	ACADIA PHARMS INC	Combination of pimavanserin and cytochrome P450 modulators	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 29, 2021

Drugs and Companies using PIMAVANSERIN TARTRATE ingredient

NCE-1 date: 29 April, 2020

Market Authorisation Date: 28 June, 2018

Treatment: Treatment of hallucinations and delusions associated with parkinson's disease psychosis

Dosage: TABLET

NUPLAZID family patents

49. Nuzyra patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10111890	PARATEK PHARMS INC	9-aminomethyl minocycline compounds and uses thereof	Aug, 2037 (12 years from now)
US10383884	PARATEK PHARMS INC	9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)	Oct, 2037 (12 years from now)
US10835542	PARATEK PHARMS INC	9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 02, 2023
Generating Antibiotic Incentives Now(GAIN)	Oct 02, 2028

Drugs and Companies using OMADACYCLINE TOSYLATE ingredient

NCE-1 date: 03 October, 2027

Market Authorisation Date: 02 October, 2018

Treatment: Treatment of subjects having bacterial skin or skin structure infection; Treatment of community acquired bacterial pneumonia

Dosage: TABLET; POWDER

NUZYRA family patents

50. Opfolda patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10857212	AMICUS THERAP US	Augmented acid alpha-glucosidase for the treatment of Pompe disease	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Sep 28, 2026

Drugs and Companies using MIGLUSTAT ingredient

Market Authorisation Date: 28 September, 2023

Treatment: The treatment of pompe patients

Dosage: CAPSULE

OPFOLDA family patents

51. Orgovyx patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10449191	SUMITOMO PHARMA	Treatment of prostate cancer	Sep, 2037 (12 years from now)
US11583526	SUMITOMO PHARMA	Treatment of prostate cancer	Sep, 2037 (12 years from now)
US10786501	SUMITOMO PHARMA	Treatment of prostate cancer	Sep, 2037 (12 years from now)
US12097198	SUMITOMO PHARMA	Treatment of prostate cancer	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 18, 2025

Drugs and Companies using RELUGOLIX ingredient

NCE-1 date: 18 December, 2024

Market Authorisation Date: 18 December, 2020

Treatment: Treatment of adult patients with advanced prostate cancer

Dosage: TABLET

ORGOVYX family patents

52. Otiprio patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11040004	ALK ABELLO	Otic gel formulations for treating otitis externa	Nov, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 10, 2018
New Indication(I-770)	Mar 02, 2021

Drugs and Companies using CIPROFLOXACIN ingredient

Market Authorisation Date: 10 December, 2015

Treatment: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus

Dosage: INJECTABLE, SUSPENSION

OTIPRIO family patents

53. Oxbryta patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10493035	GLOBAL BLOOD THERAPS	Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 25, 2024
Orphan Drug Exclusivity(ODE-281)	Nov 25, 2026
Orphan Drug Exclusivity(ODE-394)	Dec 17, 2028

Drugs and Companies using VOXELOTOR ingredient

NCE-1 date: 26 November, 2023

Market Authorisation Date: 14 October, 2022

Treatment: NA

Dosage: TABLET

OXBRYTA family patents

54. Pizensy patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10806743	BRAINTREE LABS	Method of administering lactitol to reduce plasma concentration of lactitol	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 12, 2025

Drugs and Companies using LACTITOL ingredient

NCE-1 date: 13 February, 2024

Market Authorisation Date: 12 February, 2020

Treatment: Method of treating chronic idiopathic constipation in adult patients.

Dosage: FOR SOLUTION

PIZENSY family patents

55. Procysbi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10328037 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10905662 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10548859 (Pediatric)	HORIZON	Methods for storing Cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)
US10143665 (Pediatric)	HORIZON	Methods for storing cysteamine formulations and related methods of treatment	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Apr 30, 2016
New Patient Population(NPP)	Aug 14, 2018
Orphan Drug Exclusivity(ODE-45)	Apr 30, 2020
M(M-216)	Dec 22, 2020
Orphan Drug Exclusivity(ODE)	Aug 14, 2022
Orphan Drug Exclusivity(ODE-97)	Aug 14, 2022
ODE(ODE)	Dec 22, 2024
Orphan Drug Exclusivity(ODE-162)	Dec 22, 2024
Pediatric Exclusivity(PED)	Jun 22, 2025

Drugs and Companies using CYSTEAMINE BITARTRATE ingredient

Market Authorisation Date: 30 April, 2013

Treatment: NA

Dosage: CAPSULE, DELAYED RELEASE; GRANULE, DELAYED RELEASE

PROCYSBI family patents

56. Pylarify patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10947197	PROGENICS PHARMS INC	Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPyL	Jun, 2037 (12 years from now)
US11851407	PROGENICS PHARMS INC	Synthesis of the radiolabeled prostate-specific membrane antigen (PSMA) inhibitor [18F]DCFPYL	Jun, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 26, 2026

Drugs and Companies using PIFLUFOLASTAT F-18 ingredient

NCE-1 date: 26 May, 2025

Market Authorisation Date: 26 May, 2021

Treatment: Method of positron emission tomography (pet) in men with prostate cancer

Dosage: SOLUTION

PYLARIFY family patents

57. Qlosi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9867810	ORASIS PHARMS	Ophthalmic pharmaceutical compositions and uses relating thereto	Aug, 2037 (12 years from now)
US11974986	ORASIS PHARMS	Ophthalmic pharmaceutical compositions and uses relating thereto	Aug, 2037 (12 years from now)
US11129812	ORASIS PHARMS	Ophthalmic pharmaceutical compositions and uses relating thereto	Aug, 2037 (12 years from now)
US10639297	ORASIS PHARMS	Ophthalmic pharmaceutical compositions and uses relating thereto	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Oct 17, 2026

Drugs and Companies using PILOCARPINE HYDROCHLORIDE ingredient

Market Authorisation Date: 17 October, 2023

Treatment: Treatment of presbyopia

Dosage: SOLUTION

QLOSI family patents

58. Retevmo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10112942	LOXO ONCOL ELI LILLY	Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors	Oct, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10172851	LOXO ONCOL ELI LILLY	Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors	Oct, 2037 (12 years from now)
US10137124	LOXO ONCOL ELI LILLY	Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 08, 2025
Orphan Drug Exclusivity(ODE-301)	May 08, 2027
Orphan Drug Exclusivity(ODE-302)	May 08, 2027
Orphan Drug Exclusivity(ODE-303)	May 08, 2027
New Patient Population(NPP)	May 29, 2027
Orphan Drug Exclusivity(ODE-409)	Sep 21, 2029
Orphan Drug Exclusivity(ODE-412)	Sep 21, 2029
Orphan Drug Exclusivity(ODE-484)	May 29, 2031
Orphan Drug Exclusivity(ODE-485)	May 29, 2031
Orphan Drug Exclusivity(ODE-487)	May 29, 2031

Drugs and Companies using SELPERCATINIB ingredient

NCE-1 date: 08 May, 2024

Market Authorisation Date: 08 May, 2020

Treatment: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an fda-approved test, who require systemic therapy an...

Dosage: TABLET; CAPSULE

RETEVMO family patents

59. Reyvow patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11053214	ELI LILLY AND CO	Compositions and methods related to pyridinoylpiperidine 5-HT1F agonists	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 31, 2025

Drugs and Companies using LASMIDITAN SUCCINATE ingredient

NCE-1 date: 01 February, 2024

Market Authorisation Date: 31 January, 2020

Treatment: Acute treatment of migraine

Dosage: TABLET

REYVOW family patents

60. Rezzayo patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11712459	MUNDIPHARMA	Dosing regimens for treatment of fungal infections	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Mar 22, 2028
Orphan Drug Exclusivity(ODE-426)	Mar 22, 2030
Generating Antibiotic Incentives Now(GAIN)	Mar 22, 2033

Drugs and Companies using REZAFUNGIN ACETATE ingredient

NCE-1 date: 22 March, 2032

Market Authorisation Date: 22 March, 2023

Treatment: Treatment of candidemia and invasive candidiasis with rezafungin by intravenous administration

Dosage: POWDER

REZZAYO family patents

61. Rozlytrek patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10738037	GENENTECH INC	Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11091469	GENENTECH INC	Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 15, 2024
Orphan Drug Exclusivity(ODE-265)	Aug 15, 2026
Orphan Drug Exclusivity(ODE-313)	Aug 15, 2026
New Product(NP)	Oct 20, 2026
New Patient Population(NPP)	Oct 20, 2026
Orphan Drug Exclusivity(ODE-448)	Oct 20, 2030

Drugs and Companies using ENTRECTINIB ingredient

NCE-1 date: 16 August, 2023

Market Authorisation Date: 15 August, 2019

Treatment: Treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion; Treatment of colorectal cancer that has a neurotrophic tyrosine receptor kinase(ntrk) gene fusion

Dosage: CAPSULE

ROZLYTREK family patents

62. Saxenda patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9968659	NOVO	Liraglutide in cardiovascular conditions	Jan, 2037 (12 years from now)
US9968659 (Pediatric)	NOVO	Liraglutide in cardiovascular conditions	Jul, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 25, 2015
New Product(NP)	Jan 25, 2017
New Patient Population(NPP)	Dec 04, 2023

Drugs and Companies using LIRAGLUTIDE ingredient

NCE-1 date: 25 January, 2014

Market Authorisation Date: 23 December, 2014

Treatment: Cardiovascular outcomes trial of liraglutide 1.8 mg in patients with type 2 diabetes and cardiovascular disease

Dosage: SOLUTION

SAXENDA family patents

63. Sohonos patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10864194	IPSEN	Methods for treating heterotopic ossification	Jun, 2037 (12 years from now)
US11622959	IPSEN	Methods for treating heterotopic ossification	Jun, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 16, 2028
Orphan Drug Exclusivity(ODE-439)	Aug 16, 2030

Drugs and Companies using PALOVAROTENE ingredient

NCE-1 date: 17 August, 2027

Market Authorisation Date: 16 August, 2023

Treatment: Reduction of heterotopic ossification in patients with fibrodysplasia (myositis) ossificans progressiva

Dosage: CAPSULE

SOHONOS family patents

64. Sunlenca patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10071985	GILEAD SCIENCES INC	Therapeutic compounds	Aug, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10654827	GILEAD SCIENCES INC	Therapeutic compounds	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 22, 2027

Drugs and Companies using LENACAPAVIR SODIUM ingredient

NCE-1 date: 22 December, 2026

Market Authorisation Date: 22 December, 2022

Treatment: In combination with other antiretroviral(s), for the treatment of hiv-1 infection in heavily-treatment experienced adults with multidrug resistant hiv-1 infection

Dosage: TABLET; SOLUTION

SUNLENCA family patents

65. Sunosi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10512609	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (12 years from now)
US11998639	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (12 years from now)
US10195151	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (12 years from now)
US11439597	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 17, 2024
Orphan Drug Exclusivity(ODE-254)	Jun 17, 2026

Drugs and Companies using SOLRIAMFETOL HYDROCHLORIDE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa)

Dosage: TABLET

SUNOSI family patents

66. Sutab patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11638697	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (12 years from now)
US10143656	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (12 years from now)
US11382864	BRAINTREE LABS	Solid oral sulfate salt formulations for cleansing a colon and methods of using same	Aug, 2037 (12 years from now)
US11033498	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 10, 2023

Drugs and Companies using MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE ingredient

Market Authorisation Date: 10 November, 2020

Treatment: Gastrointestinal tablets indicated for cleansing the colon in preparation for colonoscopy

Dosage: TABLET

SUTAB family patents

67. Syfovre patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11903994	APELLIS PHARMS	Dosing regimens	Feb, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Feb 22, 2026
New Chemical Entity Exclusivity(NCE)	May 14, 2026

Drugs and Companies using PEGCETACOPLAN ingredient

NCE-1 date: 14 May, 2025

Market Authorisation Date: 17 February, 2023

Treatment: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly or every other month

Dosage: SOLUTION

SYFOVRE family patents

68. Terlivaz patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10335452	MALLINCKRODT IRELAND	Method of treating patients with hepatorenal syndrome type 1	Apr, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 14, 2027
Orphan Drug Exclusivity(ODE-406)	Sep 14, 2029

Drugs and Companies using TERLIPRESSIN ACETATE ingredient

NCE-1 date: 14 September, 2026

Market Authorisation Date: 14 September, 2022

Treatment: A method to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function

Dosage: POWDER

TERLIVAZ family patents

69. Tirosint-sol patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10537538	IBSA	High-stability packaged solutions of T4 thyroid hormone	Feb, 2037 (12 years from now)
US11096913	IBSA	High-stability packaged solutions of T4 thyroid hormone	Feb, 2037 (12 years from now)

Drugs and Companies using LEVOTHYROXINE SODIUM ingredient

Market Authorisation Date: 15 December, 2016

Treatment: NA

Dosage: SOLUTION

TIROSINT-SOL family patents

70. Tlando patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11559530	VERITY	Oral testosterone undecanoate therapy	Nov, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 28, 2025

Drugs and Companies using TESTOSTERONE UNDECANOATE ingredient

Market Authorisation Date: 28 March, 2022

Treatment: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; Primary hypogonadism (congenital or acquired); Hypogonadotropic hypog...

Dosage: CAPSULE

TLANDO family patents

71. Trikafta (copackaged) patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10793547	VERTEX PHARMS INC	Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator	Dec, 2037 (13 years from now)
US11453655	VERTEX PHARMS INC	Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator	Dec, 2037 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11179367	VERTEX PHARMS INC	Pharmaceutical compositions for treating cystic fibrosis	Dec, 2037 (13 years from now)
US11517564	VERTEX PHARMS INC	Methods of treatment for cystic fibrosis	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Jun 08, 2024
New Chemical Entity Exclusivity(NCE)	Oct 21, 2024
New Product(NP)	Apr 26, 2026
Orphan Drug Exclusivity(ODE-275)	Oct 21, 2026
Orphan Drug Exclusivity(ODE-323)	Dec 21, 2027
Orphan Drug Exclusivity(ODE-357)	Jun 08, 2028
Orphan Drug Exclusivity(ODE-433)	Apr 26, 2030

Drugs and Companies using ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR ingredient

NCE-1 date: 22 October, 2023

Market Authorisation Date: 26 April, 2023

Treatment: Treatment of cystic fibrosis in patients aged 2 to <6 years who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a composition according...

Dosage: GRANULES; TABLET

TRIKAFTA (COPACKAGED) family patents

72. Tryvio patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11174247	IDORSIA	Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases	Nov, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Mar 22, 2029

Drugs and Companies using APROCITENTAN ingredient

NCE-1 date: 22 March, 2028

Market Authorisation Date: 19 March, 2024

Treatment: Treatment of hypertension in combination with other antihypertensive drugs, including an angiotensin receptor blocker, to lower blood pressure in adult patients who are not adequately controlled on ot...

Dosage: TABLET

TRYVIO family patents

73. Veklury patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11382926 (Pediatric)	GILEAD SCIENCES INC	Methods for treating Arenaviridae and Coronaviridae virus infections	Mar, 2037 (12 years from now)
US11007208 (Pediatric)	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Mar, 2037 (12 years from now)
US10695361 (Pediatric)	GILEAD SCIENCES INC	Methods for treating arenaviridae and coronaviridae virus infections	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosing Schedule(D-183)	Jan 21, 2025
New Patient Population(NPP)	Apr 25, 2025
New Chemical Entity Exclusivity(NCE)	Oct 22, 2025
M(M-301)	Jul 13, 2026
Pediatric Exclusivity(PED)	Jan 13, 2027

Drugs and Companies using REMDESIVIR ingredient

NCE-1 date: 13 January, 2026

Market Authorisation Date: 22 October, 2020

Treatment: NA

Dosage: POWDER; SOLUTION

VEKLURY family patents

74. Vevye patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10813976	HARROW EYE	Ophthalmic compositions comprising ciclosporin	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 30, 2026

Drugs and Companies using CYCLOSPORINE ingredient

Market Authorisation Date: 30 May, 2023

Treatment: NA

Dosage: SOLUTION

VEVYE family patents

75. Victoza patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9968659	NOVO NORDISK INC	Liraglutide in cardiovascular conditions	Jan, 2037 (12 years from now)
US9968659 (Pediatric)	NOVO NORDISK INC	Liraglutide in cardiovascular conditions	Jul, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 25, 2015
M(M-115)	Apr 06, 2015
M(M-176)	Apr 22, 2019
New Indication(I-750)	Aug 25, 2020
New Patient Population(NPP)	Jun 17, 2022
Pediatric Exclusivity(PED)	Dec 17, 2022

Drugs and Companies using LIRAGLUTIDE ingredient

NCE-1 date: 17 December, 2021

Market Authorisation Date: 25 January, 2010

Treatment: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with type 2 diabetes mellitus and established cardiovascular disease by administ...

Dosage: SOLUTION

VICTOZA family patents

76. Vitrakvi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10045991	BAYER HEALTHCARE	Methods of treating pediatric cancers	Apr, 2037 (12 years from now)
US11484535	BAYER HEALTHCARE	Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a] pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide	Apr, 2037 (12 years from now)
US11191766	BAYER HEALTHCARE	Methods of treating pediatric cancers	Apr, 2037 (12 years from now)
US10668072	BAYER HEALTHCARE	Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide	Apr, 2037 (12 years from now)
US10137127	BAYER HEALTHCARE	Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide	Apr, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 26, 2023
Orphan Drug Exclusivity(ODE-215)	Nov 26, 2025
Orphan Drug Exclusivity(ODE-220)	Nov 26, 2025
Orphan Drug Exclusivity(ODE-221)	Nov 26, 2025

Drugs and Companies using LAROTRECTINIB SULFATE ingredient

NCE-1 date: 26 November, 2022

Market Authorisation Date: 26 November, 2018

Treatment: Method of treating cmn, ifs, hgg, dipgs, ptc, soft tissue sarcoma, and spindle cell sarcoma solid tumors exhibiting an ntrk gene fusion in a pediatric patient with an oral solution; Method of treating...

Dosage: SOLUTION

VITRAKVI family patents

77. Vosevi patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11338007	GILEAD SCIENCES INC	Combination formulation of three antiviral compounds	Jun, 2037 (12 years from now)
US10912814	GILEAD SCIENCES INC	Combination formulation of three antiviral compounds	Jun, 2037 (12 years from now)
US11338007 (Pediatric)	GILEAD SCIENCES INC	Combination formulation of three antiviral compounds	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 18, 2022

Drugs and Companies using SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR ingredient

NCE-1 date: 18 July, 2021

Market Authorisation Date: 18 July, 2017

Treatment: Treatment of adult patients with chronic hcv infection who have genotype 1a or 3 infection and have previously been treated with an hcv regimen containing sofosbuvir without an ns5a inhibitor

Dosage: TABLET

VOSEVI family patents

78. Xerava patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11578044	TETRAPHASE PHARMS	Crystalline forms of eravacycline	Oct, 2037 (12 years from now)
US10961190	TETRAPHASE PHARMS	Crystalline forms of eravacycline	Oct, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 27, 2023
Generating Antibiotic Incentives Now(GAIN)	Aug 27, 2028

Drugs and Companies using ERAVACYCLINE DIHYDROCHLORIDE ingredient

NCE-1 date: 28 August, 2027

Market Authorisation Date: 27 August, 2018

Treatment: NA

Dosage: POWDER

XERAVA family patents

79. Xofluza patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10759814	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11306106	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-811)	Oct 16, 2022
New Chemical Entity Exclusivity(NCE)	Oct 24, 2023

Drugs and Companies using BALOXAVIR MARBOXIL ingredient

NCE-1 date: 24 October, 2022

Market Authorisation Date: 24 October, 2018

Treatment: Method for post-exposure prophylaxis of influenza

Dosage: TABLET; FOR SUSPENSION

XOFLUZA family patents

80. Xywav patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11426373	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jul 21, 2023
New Indication(I-870)	Aug 12, 2024
Orphan Drug Exclusivity(ODE-231)	Jul 21, 2027
Orphan Drug Exclusivity(ODE-361)	Jul 21, 2027
Pediatric Exclusivity(PED)	Jan 21, 2028
Orphan Drug Exclusivity(ODE-369)	Aug 12, 2028

Drugs and Companies using CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE ingredient

Market Authorisation Date: 21 July, 2020

Treatment: Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years of age and older with narcolepsy with a mixture of sodium, potassium, magnesium, and calcium salts of ghb administered ...

Dosage: SOLUTION

XYWAV family patents

81. Yorvipath patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11918628	ASCENDIS PHARMA BONE	Controlled-release PTH compound	Sep, 2037 (12 years from now)
US11890326	ASCENDIS PHARMA BONE	Controlled-release PTH compound	Sep, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11759504	ASCENDIS PHARMA BONE	PTH compounds with low peak-to-trough ratios	Sep, 2037 (12 years from now)
US11590207	ASCENDIS PHARMA BONE	Dosage regimen for a controlled-release PTH compound	Sep, 2037 (12 years from now)
US11857603	ASCENDIS PHARMA BONE	PTH compounds with low peak-to-trough ratios	Sep, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Aug 09, 2027
Orphan Drug Exclusivity(ODE-492)	Aug 09, 2031

Drugs and Companies using PALOPEGTERIPARATIDE ingredient

Market Authorisation Date: 09 August, 2024

Treatment: Treatment of hypoparathyroidism in adults

Dosage: SOLUTION

YORVIPATH family patents

82. Zoryve patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US12042487	ARCUTIS	Method for reducing side effects from administration of phosphodiesterase-4 inhibitors	Jun, 2037 (12 years from now)
US11793796	ARCUTIS	Inhibition of crystal growth of roflumilast	Jun, 2037 (12 years from now)
US12011437	ARCUTIS	Roflumilast formulations with an improved pharmacokinetic profile	Jun, 2037 (12 years from now)
US10940142	ARCUTIS	Inhibition of crystal growth of roflumilast	Jun, 2037 (12 years from now)
US12016848	ARCUTIS	Roflumilast formulations with an improved pharmacokinetic profile	Jun, 2037 (12 years from now)
US9884050	ARCUTIS	Inhibition of crystal growth of roflumilast	Jun, 2037 (12 years from now)
US12005052	ARCUTIS	Topical roflumilast formulation having improved delivery and plasma half-life	Jun, 2037 (12 years from now)
US11819496	ARCUTIS	Topical roflumilast formulation having improved delivery and plasma half-life	Jun, 2037 (12 years from now)
US9907788	ARCUTIS	Inhibition of crystal growth of roflumilast	Jun, 2037 (12 years from now)
US12005051	ARCUTIS	Topical roflumilast formulation having improved delivery and plasma half life	Jun, 2037 (12 years from now)
US11992480	ARCUTIS	Method for reducing side effects from administration of phosphodiesterase-4 inhibitors	Jun, 2037 (12 years from now)
US11129818	ARCUTIS	Topical roflumilast formulation having improved delivery and plasma half life	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 15, 2026
New Patient Population(NPP)	Oct 05, 2026
New Strength(NS)	Jul 09, 2027

Drugs and Companies using ROFLUMILAST ingredient

Market Authorisation Date: 15 December, 2023

Treatment: Topical treatment of mild to moderate atopic dermatitis; Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)

Dosage: CREAM

ZORYVE family patents

83. Ztalmy patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10603308	MARINUS	Methods and compositions for treatment of epileptic disorders	Aug, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 01, 2027
Orphan Drug Exclusivity(ODE-395)	Jun 01, 2029

Drugs and Companies using GANAXOLONE ingredient

NCE-1 date: 01 June, 2026

Market Authorisation Date: 01 June, 2022

Treatment: Treatment of seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 years of age and older

Dosage: SUSPENSION

ZTALMY family patents

84. Zulresso patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10940156	SAGE THERAP	Neuroactive steroids, compositions, and uses thereof	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 17, 2024
New Patient Population(NPP)	Jun 16, 2025

Drugs and Companies using BREXANOLONE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: Method of treating postpartum depression

Dosage: SOLUTION

ZULRESSO family patents

85. Zurzuvae patent expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11236121	BIOGEN INC	Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid	Aug, 2037 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11884696	BIOGEN INC	Crystalline 19-nor C3,3-disubstituted C21-n-pyrazolyl steroid	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 31, 2028

Drugs and Companies using ZURANOLONE ingredient

NCE-1 date: 01 November, 2027

Market Authorisation Date: 31 October, 2023

Treatment: Method of treating postpartum depression

Dosage: CAPSULE

ZURZUVAE family patents

List of large molecules

1. List of Eylea large molecules

Patent Number	Company	Patent Title	Patent Expiry
US10669594	REGENERON PHARMACEUTICALS, INC.	Compositions and methods for detecting a biological contaminant	Feb, 2037 (12 years from now)
US11918785	REGENERON PHARMACEUTICALS, INC.	Devices and methods for overfilling drug containers	Jun, 2037 (12 years from now)
US10182969	REGENERON PHARMACEUTICALS, INC.	Aseptic piercing system and method	Jul, 2037 (12 years from now)
USD961377	REGENERON PHARMACEUTICALS, INC.	Packaging	Aug, 2037 (12 years from now)
USD961376	REGENERON PHARMACEUTICALS, INC.	Packaging	Aug, 2037 (12 years from now)
US11577025	REGENERON PHARMACEUTICALS, INC.	Devices and methods for overfilling drug containers	Oct, 2037 (12 years from now)
US11680930	REGENERON PHARMACEUTICALS, INC.	Methods and systems for chromatography data analysis	Oct, 2037 (12 years from now)

Ingredients: AFLIBERCEPT

2. List of Prolia And Xgeva large molecules

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
US11275090	AMGEN INC.	Quantitation of glycan moiety in recombinant glycoproteins	Jul, 2037 (12 years from now)
US11098079	AMGEN INC.	Charged depth filtration of antigen-binding proteins	Jul, 2037 (12 years from now)

Ingredients: DENOSUMAB

Application	Filing Date	Opposition Party	Legal Status

EP17716354A	2022-02-08	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
267 mg	15 Oct, 2018	9	03 Jan, 2022	30 Aug, 2033	Eligible
267 mg and 801 mg	15 Oct, 2018	17	25 Jan, 2022	30 Aug, 2033	Eligible
534 mg	15 Oct, 2018	2	19 Jul, 2022	30 Aug, 2033	Eligible

Application	Filing Date	Opposition Party	Legal Status

EP17714100A	2022-05-31	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP17714100A	2022-05-31	Gill Jennings & Every LLP	Granted and Under Opposition

Strength	Dosage	Availability
15MG;16MG	CAPSULE, PELLETS	Prescription
6MG;6MG	CAPSULE, PELLETS	Prescription

Strength	Dosage	Availability
534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	Discontinued
801MG	TABLET	Prescription
267MG	TABLET	Prescription

Strength	Dosage	Availability
10MG	TABLET, ORALLY DISINTEGRATING	Discontinued
15MG	TABLET, ORALLY DISINTEGRATING	Discontinued
2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING	Discontinued
20MG	TABLET, ORALLY DISINTEGRATING	Discontinued
5MG	TABLET, ORALLY DISINTEGRATING	Discontinued

Strength	Dosage	Availability
EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION	Prescription
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION	Prescription
EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION	Discontinued

Strength	Dosage	Availability
EQ 0.18MG BASE	FILM	Prescription
EQ 0.12MG BASE	FILM	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
40 mg and 80 mg	12 Apr, 2021	4		10 Aug, 2040
60 mg	14 Feb, 2022	1		10 Aug, 2040

Strength	Dosage	Availability
EQ 80MG BASE	CAPSULE	Prescription
EQ 40MG BASE	CAPSULE	Prescription
EQ 60MG BASE	CAPSULE	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10195214	May, 2019	FWD Entered	Corcept Therapeutics, Inc.	Teva Pharmaceuticals USA, Inc.

Strength	Dosage	Availability
EQ 6.14MG BASE;15MG	TABLET	Prescription
EQ 8.19MG BASE;20MG	TABLET	Prescription

Strength	Dosage	Availability
7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE	Prescription
4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE	Prescription
6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE	Prescription
9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10286036	February, 2022	Terminated-Settled	Aurinia Pharmaceuticals Inc.	Sun Pharmaceutical Industries Ltd. et al.

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
34 mg	29 Apr, 2020	5		27 Aug, 2038
10 mg	29 Apr, 2020	1		03 Jun, 2028

Strength	Dosage	Availability
EQ 150MG BASE	TABLET	Prescription
EQ 100MG BASE/VIAL	POWDER	Prescription

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg and 75 mg	11 May, 2020	1		16 Aug, 2036
75 mg/Packet and 300 mg/Packet	16 Dec, 2021	1		16 Aug, 2036

Strength	Dosage	Availability
EQ 75MG BASE	CAPSULE, DELAYED RELEASE	Prescription
EQ 75MG BASE/PACKET	GRANULE, DELAYED RELEASE	Prescription
EQ 300MG BASE/PACKET	GRANULE, DELAYED RELEASE	Prescription
EQ 25MG BASE	CAPSULE, DELAYED RELEASE	Prescription

Strength	Dosage	Availability
40MG	TABLET	Prescription
80MG	CAPSULE	Prescription
120MG	TABLET	Prescription
160MG	TABLET	Prescription

Strength	Dosage	Availability
EQ 100MG BASE	TABLET	Prescription
EQ 50MG BASE	TABLET	Prescription
EQ 200MG BASE	TABLET	Discontinued

Application	Filing Date	Opposition Party	Legal Status

EP17710160A	2022-05-04	STADA Arzneimittel AG	Granted and Under Opposition
EP17710160A	2022-05-04	Dr. Schön, Neymeyr & Partner Patentanwälte mbB	Granted and Under Opposition
EP17710160A	2022-05-03	SANDOZ AG	Granted and Under Opposition
EP17710160A	2022-05-03	Adalvo Ltd.	Granted and Under Opposition
EP17710160A	2022-04-28	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition

Strength	Dosage	Availability
EQ 300MG BASE	TABLET	Prescription
EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP17794903A	2021-04-21	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	Granted and Under Opposition

Pharsight

Pharsight

Drug Patents Expiring in 2037

1. Adlarity patent expiration

ADLARITY family patents

2. Airduo Digihaler patent expiration

AIRDUO DIGIHALER family patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years. Get the exclusive patent insights now. Don't be the last to know. Download Report 3. Akeega patent expiration

AKEEGA family patents

4. Akynzeo patent expiration

AKYNZEO family patents

5. Amzeeq patent expiration

AMZEEQ family patents

6. Armonair Digihaler patent expiration

ARMONAIR DIGIHALER family patents

7. Atorvaliq patent expiration

ATORVALIQ family patents

8. Auvi-q patent expiration

AUVI-Q family patents

9. Azstarys patent expiration

AZSTARYS family patents

10. Bludigo patent expiration

BLUDIGO family patents

11. Brukinsa patent expiration

BRUKINSA family patents

12. Cabometyx patent expiration

CABOMETYX family patents

13. Calcium Gluconate In Sodium Chloride patent expiration

CALCIUM GLUCONATE IN SODIUM CHLORIDE family patents

14. Cequa patent expiration

CEQUA family patents

15. Definity patent expiration

DEFINITY family patents

16. Definity Rt patent expiration

DEFINITY RT family patents

17. Dextenza patent expiration

DEXTENZA family patents

18. Drizalma Sprinkle patent expiration

DRIZALMA SPRINKLE family patents

19. Edurant Ped patent expiration

EDURANT PED family patents

20. Entresto Sprinkle patent expiration

ENTRESTO SPRINKLE family patents

21. Esbriet patent expiration

ESBRIET family patents

22. Evekeo Odt patent expiration

EVEKEO ODT family patents

23. Fintepla patent expiration

FINTEPLA family patents

24. Firdapse patent expiration

FIRDAPSE family patents

25. Fleqsuvy patent expiration

FLEQSUVY family patents

26. Fluorescein Sodium And Benoxinate Hydrochloride patent expiration

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE family patents

27. Galafold patent expiration

GALAFOLD family patents

28. Giapreza patent expiration

GIAPREZA family patents

29. Gloperba patent expiration

GLOPERBA family patents

30. Goprelto patent expiration

GOPRELTO family patents

31. Hemady patent expiration

HEMADY family patents

32. Igalmi patent expiration

IGALMI family patents

33. Ingrezza patent expiration

INGREZZA family patents

34. Ingrezza Sprinkle patent expiration

INGREZZA SPRINKLE family patents

35. Inlyta patent expiration

INLYTA family patents

36. Iqirvo patent expiration

IQIRVO family patents

37. Katerzia patent expiration

KATERZIA family patents

38. Korlym patent expiration

KORLYM family patents

39. Krazati patent expiration

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

3. Akeega patent expiration

Strength	Dosage	Availability
150MCG/ML	SOLUTION	Prescription
137MCG/ML	SOLUTION	Prescription
25MCG/ML	SOLUTION	Prescription
125MCG/ML	SOLUTION	Prescription
75MCG/ML	SOLUTION	Prescription
44MCG/ML	SOLUTION	Prescription
100MCG/ML	SOLUTION	Prescription
88MCG/ML	SOLUTION	Prescription
112MCG/ML	SOLUTION	Prescription
62.5MCG/ML	SOLUTION	Prescription
13MCG/ML	SOLUTION	Prescription
175MCG/ML	SOLUTION	Prescription
50MCG/ML	SOLUTION	Prescription
200MCG/ML	SOLUTION	Prescription
37.5MCG/ML	SOLUTION	Prescription

Strength	Dosage	Availability
80MG, 60MG, 40MG;59.5MG	GRANULES	Prescription
100MG,75MG,50MG; 150MG	TABLET	Prescription
50MG,37.5MG,25MG; 75MG	TABLET	Prescription
100MG, 75MG, 50MG;75MG	GRANULES	Prescription

Strength	Dosage	Availability
100MG/VIAL	POWDER	Prescription
100MG/20ML (5MG/ML)	SOLUTION	Prescription

Strength	Dosage	Availability
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	Discontinued
80MG	TABLET	Prescription
40MG	TABLET	Prescription
2MG/ML	FOR SUSPENSION	Prescription

Strength	Dosage	Availability
EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)	SOLUTION	Prescription
EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)	SOLUTION	Prescription
EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)	SOLUTION	Prescription

Strength	Dosage	Availability
25MG	CAPSULE	Prescription
30MG	CAPSULE	Prescription
20MG	CAPSULE	Prescription