Pharsight

1. List of Airduo Digihaler drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11344685 (Pediatric)	TEVA PHARM	Drug delivery device with electronics	Mar, 2040 (17 years from now)
US11439777	TEVA PHARM	Drug delivery device with electronics	May, 2040 (17 years from now)
US11464923	TEVA PHARM	Inhaler system	Jun, 2040 (17 years from now)
US11173259	TEVA PHARM	Drug delivery device with electronics and power management	Jul, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
M	Jul 9, 2024
Pediatric Exclusivity (PED)	Jan 9, 2025

Drugs and Companies using FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE ingredient

Market Authorisation Date: 27 January, 2017

Treatment: NA

Dosage: POWDER;INHALATION

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

2. List of Ameluz drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11235169	BIOFRONTERA	Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device	Oct, 2040 (17 years from now)

Drugs and Companies using AMINOLEVULINIC ACID HYDROCHLORIDE ingredient

Market Authorisation Date: 10 May, 2016

Treatment: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light

Dosage: GEL;TOPICAL

Strength	Dosage	Availability
10%	GEL;TOPICAL	Prescription

3. List of Armonair Digihaler drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11344685 (Pediatric)	TEVA PHARM	Drug delivery device with electronics	Mar, 2040 (17 years from now)
US11439777	TEVA PHARM	Drug delivery device with electronics	May, 2040 (17 years from now)
US11464923	TEVA PHARM	Inhaler system	Jun, 2040 (17 years from now)
US11173259	TEVA PHARM	Drug delivery device with electronics and power management	Jul, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Patient Population (NPP)	Jul 9, 2024
New Strength (NS)	Jul 9, 2024
Pediatric Exclusivity (PED)	Jan 9, 2025

Drugs and Companies using FLUTICASONE PROPIONATE ingredient

Market Authorisation Date: 27 January, 2017

Treatment: NA

Dosage: POWDER;INHALATION

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

4. List of Auvelity drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10940124	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (16 years from now)
US10780064	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (16 years from now)
US10966942	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (16 years from now)
US10925842	AXSOME	Bupropion as a modulator of drug activity	Jan, 2040 (16 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Aug 18, 2025

Drugs and Companies using BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE ingredient

Market Authorisation Date: 18 August, 2022

Treatment: Dextromethorphan and bupropion in combination to treat major depressive disorder

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
105MG;45MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

5. List of Emerphed drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11241400	NEXUS PHARMS	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same	May, 2040 (17 years from now)
US11478436	NEXUS PHARMS	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same	May, 2040 (17 years from now)
US11090278	NEXUS PHARMS	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same	May, 2040 (17 years from now)
US11464752	NEXUS PHARMS	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same	May, 2040 (17 years from now)

Drugs and Companies using EPHEDRINE SULFATE ingredient

Market Authorisation Date: 17 April, 2020

Treatment: Use of ephedrine sulfate for treating hypotension

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg/10 mL	14 Oct, 2021	1		16 May, 2040

Strength	Dosage	Availability
50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription

6. List of Ephedrine Sulfate drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10869845	ENDO VENTURES	Ephedrine compositions and methods	Jan, 2040 (16 years from now)

Drugs and Companies using EPHEDRINE SULFATE ingredient

Market Authorisation Date: 16 October, 2020

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
50MG/10ML (5MG/ML)	SOLUTION;INTRAVENOUS	Prescription

7. List of Eprontia drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11433046	AZURITY	Compositions and methods for treating epilepsy, seizures and other conditions	Aug, 2040 (17 years from now)

Drugs and Companies using TOPIRAMATE ingredient

Market Authorisation Date: 05 November, 2021

Treatment: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older; Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; Indicated for the preventive treatment of migraine in patients 12 years and older

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg/mL	06 Oct, 2022	1		21 Aug, 2040

Strength	Dosage	Availability
25MG/ML	SOLUTION;ORAL	Prescription

8. List of Epsolay drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10945987	GALDERMA LABS LP	Method for providing early onset of action in the treatment of rosacea	Feb, 2040 (17 years from now)
US10933046	GALDERMA LABS LP	Method for treatment of rosacea in patients aged 65 years and older	Feb, 2040 (17 years from now)
US11426378	GALDERMA LABS LP	Method for long-term treatment of rosacea	Aug, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Apr 22, 2025

Drugs and Companies using BENZOYL PEROXIDE ingredient

Market Authorisation Date: 22 April, 2022

Treatment: Topical treatment of inflammatory lesions of rosacea in adults 18 years of age and older; Topical treatment of inflammatory lesions of rosacea in adults 65 years of age and older

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
5%	CREAM;TOPICAL	Prescription

9. List of Farxiga drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10973836	ASTRAZENECA AB	Methods of treating heart failure with reduced ejection fraction	Mar, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
M	Feb 22, 2022
New Indication (I)	Oct 18, 2022

Drugs and Companies using DAPAGLIFLOZIN ingredient

Market Authorisation Date: 08 January, 2014

Treatment: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without type ii diabetes

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	08 Jan, 2018	20	22 Feb, 2022	26 May, 2030	Deferred

Strength	Dosage	Availability
5MG	TABLET;ORAL	Prescription
10MG	TABLET;ORAL	Prescription

10. List of Fyarro drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11497737	AADI	NA	Oct, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Nov 22, 2024

Drugs and Companies using SIROLIMUS ingredient

Market Authorisation Date: 22 November, 2021

Treatment: NA

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
100MG/VIAL	POWDER;INTRAVENOUS	Prescription

11. List of Hetlioz Lq drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11202770	VANDA PHARMS INC	Liquid tasimelteon formulations and methods of use thereof	Dec, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Dec 1, 2023
Orphan Drug Exclusivity (ODE)	Dec 1, 2027

Drugs and Companies using TASIMELTEON ingredient

Market Authorisation Date: 01 December, 2020

Treatment: NA

Dosage: SUSPENSION;ORAL

Strength	Dosage	Availability
4MG/ML	SUSPENSION;ORAL	Prescription

12. List of Ingrezza drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10940141	NEUROCRINE	Methods for the administration of certain VMAT2 inhibitors	Aug, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 11, 2022

Drugs and Companies using VALBENAZINE TOSYLATE ingredient

NCE-1 date: April, 2021

Market Authorisation Date: 11 April, 2017

Treatment: Treatment of tardive dyskinesia

Dosage: CAPSULE;ORAL

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 40MG BASE	CAPSULE;ORAL	Prescription
EQ 60MG BASE	CAPSULE;ORAL	Prescription
EQ 80MG BASE	CAPSULE;ORAL	Prescription

13. List of Livmarli drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11229647	MIRUM	Methods for treating cholestasis	Feb, 2040 (17 years from now)
US11497745	MIRUM	NA	Feb, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Sep 29, 2026
Orphan Drug Exclusivity (ODE)	Sep 29, 2028

Drugs and Companies using MARALIXIBAT CHLORIDE ingredient

NCE-1 date: September, 2025

Market Authorisation Date: 29 September, 2021

Treatment: Treatment of cholestatic pruritus in patients with alagille syndrome (algs)

Dosage: SOLUTION;ORAL

Strength	Dosage	Availability
EQ 9.5MG BASE/ML	SOLUTION;ORAL	Prescription

14. List of Lumakras drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US11236091	AMGEN INC	Solid state forms	May, 2040 (17 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11426404	AMGEN INC	Dosing of KRAS inhibitor for treatment of cancers	Aug, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 28, 2026
Orphan Drug Exclusivity (ODE)	May 28, 2028

Drugs and Companies using SOTORASIB ingredient

NCE-1 date: May, 2025

Market Authorisation Date: 28 May, 2021

Treatment: Treatment of adult patients with kras g12c-mutated locally advanced or metastatic non-small cell lung cancer (nsclc), as determined by an fda-approved test, who have received at least one prior systemic therapy

Dosage: TABLET;ORAL

Strength	Dosage	Availability
120MG	TABLET;ORAL	Prescription

15. List of Mycapssa drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11141457	AMRYT	Oral octreotide therapy and contraceptive methods	Dec, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Jun 26, 2023

Drugs and Companies using OCTREOTIDE ACETATE ingredient

Market Authorisation Date: 26 June, 2020

Treatment: Use of oral octreotide for long-term maintenance treatment in acromegaly patients while avoiding concomitant administration of levonorgestrel

Dosage: CAPSULE, DELAYED RELEASE;ORAL

Strength	Dosage	Availability
EQ 20MG BASE	CAPSULE, DELAYED RELEASE;ORAL	Prescription

16. List of Proair Digihaler drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11439777	TEVA BRANDED PHARM	Drug delivery device with electronics	May, 2040 (17 years from now)
US11464923	TEVA BRANDED PHARM	Inhaler system	Jun, 2040 (17 years from now)
US11173259	TEVA BRANDED PHARM	Drug delivery device with electronics and power management	Jul, 2040 (17 years from now)

Drugs and Companies using ALBUTEROL SULFATE ingredient

Market Authorisation Date: 31 March, 2015

Treatment: NA

Dosage: POWDER, METERED;INHALATION

Strength	Dosage	Availability
EQ 0.09MG BASE/INH	POWDER, METERED;INHALATION	Prescription

17. List of Qdolo drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11103452	ATHENA	Tramadol hydrochloride solution	Sep, 2040 (17 years from now)

Drugs and Companies using TRAMADOL HYDROCHLORIDE ingredient

Market Authorisation Date: 01 September, 2020

Treatment: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Dosage: SOLUTION;ORAL

Strength	Dosage	Availability
5MG/ML	SOLUTION;ORAL	Prescription

18. List of Qinlock drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10966966	DECIPHERA PHARMS	Methods of treating gastrointestinal stromal tumors	Aug, 2040 (17 years from now)
US11266635	DECIPHERA PHARMS	Methods of treating gastrointestinal stromal tumors	Aug, 2040 (17 years from now)
US11426390	DECIPHERA PHARMS	Methods of treating gastrointestinal stromal tumors	Aug, 2040 (17 years from now)
US11433056	DECIPHERA PHARMS	Methods of treating gastrointestinal stromal tumors	Aug, 2040 (17 years from now)
US11344536	DECIPHERA PHARMS	Methods of treating gastrointestinal stromal tumors	Aug, 2040 (17 years from now)
US11185535	DECIPHERA PHARMS	Amorphous kinase inhibitor formulations and methods of use thereof	Dec, 2040 (17 years from now)
US11395818	DECIPHERA PHARMS	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea	Dec, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 15, 2025
Orphan Drug Exclusivity (ODE)	May 15, 2027

Drugs and Companies using RIPRETINIB ingredient

NCE-1 date: May, 2024

Market Authorisation Date: 15 May, 2020

Treatment: Treatment of advanced gastrointestinal stromal tumor in patients having progressed from a first line administration of imatinib, a second line administration of sunitinib, and a third line administration of regorafenib; Treatment of gastrointestinal stromal tumors in patients suffering from palmer-planter erythrodysesthesia syndrome; Treatment of gastrointestinal stromal tumors in patients being treated concurrently with a cyp3a4 inhibitor; Method of treating gastrointestinal stromal tumors in patients suffering from grade 2 or grade 3 myalgia while being administered ripretinib daily; Treatment of gastrointestinal stromal tumors in patients suffering from hypertension

Dosage: TABLET;ORAL

19. List of Recorlev drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11278547	STRONGBRIDGE	Methods of treating disease with levoketoconazole	Mar, 2040 (17 years from now)
US11020393	STRONGBRIDGE	Methods of treating disease with levoketoconazole	Mar, 2040 (17 years from now)

Drugs and Companies using LEVOKETOCONAZOLE ingredient

Market Authorisation Date: 30 December, 2021

Treatment: During levoketoconazole dosage titration for the treatment of cushing's syndrome in patients who concomitantly use metformin, monitoring glycemia, kidney function and vitamin b-12 and adjusting dosage of metformin as needed

Dosage: TABLET;ORAL

20. List of Scemblix drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US11407735	NOVARTIS	Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide	May, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 29, 2026
Orphan Drug Exclusivity (ODE)	Oct 29, 2028

Drugs and Companies using ASCIMINIB HYDROCHLORIDE ingredient

NCE-1 date: October, 2025

Market Authorisation Date: 29 October, 2021

Treatment: NA

Dosage: TABLET;ORAL

21. List of Sunosi drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10940133	JAZZ	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (17 years from now)

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

Drugs and Companies using SOLRIAMFETOL HYDROCHLORIDE ingredient

NCE-1 date: June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (osa) in a patient with moderate renal impairment

Dosage: TABLET;ORAL

22. List of Tymlos drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11255842	RADIUS HEALTH INC	Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog	Jan, 2040 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 28, 2022
M	Sep 20, 2024

Drugs and Companies using ABALOPARATIDE ingredient

NCE-1 date: April, 2021

Market Authorisation Date: 28 April, 2017

Treatment: Use for detecting neutralizing antibodies

Dosage: SOLUTION;SUBCUTANEOUS

availability in other generic markets.

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List of large molecules

1. List of Elyea large molecules

Patent Number	Company	Patent Title	Patent Expiry
USD961376	REGENERON PHARMACEUTICALS, INC.	Packaging	Aug, 2040 (17 years from now)
US11439758	REGENERON PHARMACEUTICALS, INC.	Devices and methods for precision dose delivery	Aug, 2040 (17 years from now)
US11433186	REGENERON PHARMACEUTICALS, INC.	Devices and methods for precision dose delivery	Aug, 2040 (17 years from now)
USD961377	REGENERON PHARMACEUTICALS, INC.	Packaging	Aug, 2040 (17 years from now)
US11472861	REGENERON PHARMACEUTICALS, INC.	Methods for producing aflibercept in chemically defined media having reduced aflibercept variants	Aug, 2040 (17 years from now)
US11459374	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11459373	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)

Ingredients: AFLIBERCEPT

2. List of Eylea large molecules

Patent Number	Company	Patent Title	Patent Expiry
US11053280	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11306135	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11299532	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11186625	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11174283	REGENERON PHARMACEUTICALS, INC.	Anti-VEGF protein compositions and methods for producing the same	Aug, 2040 (17 years from now)
US11104715	REGENERON PHARMACEUTICALS, INC.	Methods for producing aflibercept in chemically defined media having reduced aflibercept variants	Aug, 2040 (17 years from now)