Pharsight

1. List of Akynzeo 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).
US11559523	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)

Drugs and Companies using NETUPITANT; PALONOSETRON HYDROCHLORIDE ingredient

Market Authorisation Date: 10 October, 2014

Treatment: Method of treating emesis

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
300MG;EQ 0.5MG BASE	CAPSULE;ORAL	Prescription

2. 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).
US11357935 (Pediatric)	TEVA PHARM	Drug delivery device with electronics	Mar, 2039 (16 years from now)
US11464923 (Pediatric)	TEVA PHARM	Inhaler system	Dec, 2040 (17 years from now)
US11439777 (Pediatric)	TEVA PHARM	Drug delivery device with electronics	Nov, 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

3. List of Atorvaliq 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).
US11369567	CMP DEV LLC	Aqueous suspension suitable for oral administration	Jun, 2037 (14 years from now)

Drugs and Companies using ATORVASTATIN CALCIUM ingredient

Market Authorisation Date: 01 February, 2023

Treatment: NA

Dosage: SUSPENSION;ORAL

Strength	Dosage	Availability
20MG/5ML	SUSPENSION;ORAL	Prescription

4. List of Austedo 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).
US11564917	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (12 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Apr 3, 2024
M (M)	Jun 24, 2024
Pediatric Exclusivity (PED)	Oct 3, 2024

Drugs and Companies using DEUTETRABENAZINE ingredient

Market Authorisation Date: 03 April, 2017

Treatment: Treatment of tardive dyskinesia

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
6 mg, 9 mg and 12 mg	05 Apr, 2021	2		07 Mar, 2036

Strength	Dosage	Availability
6MG	TABLET;ORAL	Prescription
9MG	TABLET;ORAL	Prescription
12MG	TABLET;ORAL	Prescription

5. List of Austedo Xr drug patents

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US8524733	September, 2021	Terminated-Denied	Auspex Pharmaceuticals, Inc.	Apotex Inc.

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.
US9550780	TEVA	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (10 years from now)
US8524733	TEVA	Benzoquinoline inhibitors of vesicular monoamine transporter 2	Apr, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11179386	TEVA	Analogs of deutetrabenazine, their preparation and use	Mar, 2038 (14 years from now)
US10959996	TEVA	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (12 years from now)
US11311488	TEVA	Osmotic dosage forms comprising deutetrabenazine and methods of use thereof	Jun, 2041 (18 years from now)
US11564917	TEVA	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (12 years from now)
US11446291	TEVA	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (12 years from now)
US11357772	TEVA	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (12 years from now)

Drugs and Companies using DEUTETRABENAZINE ingredient

Market Authorisation Date: 17 February, 2023

Treatment: Treatment of tardive dyskinesia; A method of treating huntington's chorea

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
6MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
12MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
24MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

AUSTEDO XR family patents

United States

Japan

China

Australia

European Union

Hong Kong

Canada

Spain

Brazil

Korea, Republic of

South Africa

Israel

Denmark

Portugal

Singapore

Croatia

New Zealand

Argentina

Mexico

Lithuania

Hungary

Poland

Chile

Colombia

Norway

Peru

Taiwan, Province of China

India

Cyprus

Slovenia

6. List of Brenzavvy 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.
US8802637	THERACOSBIO	Benzylbenzene derivatives and methods of use	Aug, 2028 (5 years from now)
US7838499	THERACOSBIO	Benzylbenzene derivatives and methods of use	Jan, 2029 (5 years from now)
US8987323	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	May, 2032 (9 years from now)
US10981942	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	Jun, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10533032	THERACOSBIO	Crystalline form of benzylbenzene SGLT2 inhibitor	Jul, 2031 (8 years from now)
US8106021	THERACOSBIO	Benzylbenzene derivatives and methods of use	Aug, 2028 (5 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jan 20, 2028

Drugs and Companies using BEXAGLIFLOZIN ingredient

NCE-1 date: 2027-01-20

Market Authorisation Date: 20 January, 2023

Treatment: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Dosage: TABLET;ORAL

Strength	Dosage	Availability
20MG	TABLET;ORAL	Prescription

7. List of Brukinsa 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).
US11591340	BEIGENE	NA	Aug, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 14, 2024
Orphan Drug Exclusivity (ODE)	Sep 14, 2028
New Indication (I)	Sep 14, 2024

Drugs and Companies using ZANUBRUTINIB ingredient

NCE-1 date: 2023-11-15

Market Authorisation Date: 14 November, 2019

Treatment: For the treatment of patients with waldenstrom's macroglobulinemia; Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll); Treatment of adult patients with chronic lymphocytic leukemia; Relapsed or refractory marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based regimen; Treatment of adult patients with small lymphocytic lymphoma

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
80MG	CAPSULE;ORAL	Prescription

8. List of Dyanavel Xr 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).
US11590228	TRIS PHARMA INC	NA	Sep, 2036 (13 years from now)

Drugs and Companies using AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE ingredient

Market Authorisation Date: 19 October, 2015

Treatment: Method of treating attention deficit hyperactivity disorder

Dosage: SUSPENSION, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
2MG/ML;EQ 0.5MG BASE/ML	SUSPENSION, EXTENDED RELEASE;ORAL	Prescription

9. List of Dyanavel Xr 10 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).
US11590081	TRIS PHARMA INC	NA	Sep, 2038 (15 years from now)

Drugs and Companies using AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE ingredient

Market Authorisation Date: 04 November, 2021

Treatment: Method of treating attention deficit hyperactivity disorder

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Dosage	Availability
8MG;EQ 2MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
12MG;EQ 3MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
16MG;EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
4MG;EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription

10. List of Emerphed 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).
US11571398	NEXUS PHARMS	NA	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

11. List of Evrysdi 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).
US11534444	GENENTECH INC	Treatment of SMA	Oct, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	May 27, 2029
New Chemical Entity Exclusivity (NCE)	Aug 7, 2025
New Patient Population (NPP)	May 27, 2025

Drugs and Companies using RISDIPLAM ingredient

NCE-1 date: 2024-08-07

Market Authorisation Date: 07 August, 2020

Treatment: Treatment of spinal muscular atrophy

Dosage: FOR SOLUTION;ORAL

Strength	Dosage	Availability
0.75MG/ML	FOR SOLUTION;ORAL	Prescription

12. List of Hetlioz 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.
US11566011	VANDA PHARMS INC	Highly purified pharmaceutical grade tasimelteon	Feb, 2035 (11 years from now)

Exclusivity	Exclusivity Expiration
New Indication (I)	Dec 1, 2023
Orphan Drug Exclusivity (ODE)	Dec 1, 2027

Drugs and Companies using TASIMELTEON ingredient

Market Authorisation Date: 31 January, 2014

Treatment: NA

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
20 mg	31 Jan, 2018	3	12 Dec, 2022	17 May, 2034	Eligible Deferred

Strength	Dosage	Availability
20MG	CAPSULE;ORAL	Prescription

13. List of Hetlioz Lq 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.
US11566011	VANDA PHARMS INC	Highly purified pharmaceutical grade tasimelteon	Feb, 2035 (11 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

14. List of Jatenzo 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).
US11564933	TOLMAR	Methods of treating testosterone deficiency	Apr, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Mar 27, 2022

Drugs and Companies using TESTOSTERONE UNDECANOATE ingredient

Market Authorisation Date: 27 March, 2019

Treatment: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
158MG	CAPSULE;ORAL	Prescription
198MG	CAPSULE;ORAL	Prescription
237MG	CAPSULE;ORAL	Prescription

15. List of Jaypirca 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.
US10695323	LOXO ONCOL	Compounds useful as kinase inhibitors	Dec, 2036 (13 years from now)
US10342780	LOXO ONCOL	Compounds useful as kinase inhibitors	Dec, 2036 (13 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10918622	LOXO ONCOL	Compounds useful as kinase inhibitors	Dec, 2036 (13 years from now)
US10464905	LOXO ONCOL	Compounds useful as kinase inhibitors	Dec, 2036 (13 years from now)

Drugs and Companies using PIRTOBRUTINIB ingredient

Market Authorisation Date: 27 January, 2023

Treatment: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a btk inhibitor

Dosage: TABLET;ORAL

Strength	Dosage	Availability
50MG	TABLET;ORAL	Prescription
100MG	TABLET;ORAL	Prescription

16. List of Jesduvroq 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.
US11117871	GLAXOSMITHKLINE	Crystalline forms of GSK1278863, preparation method and pharmaceutical use thereof	Mar, 2038 (14 years from now)
US8324208	GLAXOSMITHKLINE	Prolyl hydroxylase inhibitors	Dec, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8815884	GLAXOSMITHKLINE	Prolyl hydroxylase inhibitors	Jun, 2027 (4 years from now)
US8557834	GLAXOSMITHKLINE	Prolyl hydroxylase inhibitors	Jun, 2027 (4 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Feb 1, 2028

Drugs and Companies using DAPRODUSTAT ingredient

NCE-1 date: 2027-02-01

Market Authorisation Date: 01 February, 2023

Treatment: Treatment of anemia due to chronic kidney disease; A method of treating anemia

Dosage: TABLET;ORAL

Strength	Dosage	Availability
1MG	TABLET;ORAL	Prescription
2MG	TABLET;ORAL	Prescription
4MG	TABLET;ORAL	Prescription
6MG	TABLET;ORAL	Prescription
8MG	TABLET;ORAL	Prescription

17. List of Kalydeco 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).
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2027

Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 17 March, 2015

Treatment: Treatment of cf in a patient age 4 months to <6 years who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11564916

Dosage: GRANULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
150 mg	10 Jun, 2020	1		13 Aug, 2029
25 mg, 50 mg and 75 mg	13 Apr, 2022	1		27 Feb, 2033

Strength	Dosage	Availability
25MG/PACKET	GRANULE;ORAL	Prescription
50MG/PACKET	GRANULE;ORAL	Prescription
75MG/PACKET	GRANULE;ORAL	Prescription

18. List of Kalydeco 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).
US11564916	VERTEX PHARMS	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2027

Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 31 January, 2012

Treatment: Treatment of cf in a patient age 6 years and older who has one mutation in the cftr gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11564916

Dosage: TABLET;ORAL

19. List of Lenvima 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).
US11090386	EISAI INC	Method for suppressing bitterness of quinoline derivative	Feb, 2036 (12 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Aug 15, 2025
M (M)	Dec 19, 2024
New Indication (I)	Aug 10, 2024

Drugs and Companies using LENVATINIB MESYLATE ingredient

Market Authorisation Date: 13 February, 2015

Treatment: Treatment with lenvima by administering lenvima as a suspension

Dosage: CAPSULE;ORAL

20. List of Liletta 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).
US11571328	MEDICINES360	NA	Sep, 2040 (17 years from now)

Drugs and Companies using LEVONORGESTREL ingredient

Market Authorisation Date: 26 February, 2015

Treatment: NA

Dosage: INTRAUTERINE DEVICE;INTRAUTERINE

21. List of Mekinist 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).
US7378423 (Pediatric)	NOVARTIS	Pyrimidine compound and medical use thereof	Nov, 2027 (4 years from now)
US8835443 (Pediatric)	NOVARTIS	Pyrimidine compound and medical use thereof	Dec, 2025 (2 years from now)
US8580304 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US9155706 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US8952018 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Apr, 2031 (8 years from now)
US9271941 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US8703781 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors	Apr, 2031 (8 years from now)
US10869869 (Pediatric)	NOVARTIS	Method of adjuvant cancer treatment	Mar, 2034 (10 years from now)
US9399021 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jun 22, 2024
New Indication (I)	Jun 22, 2025
Pediatric Exclusivity (PED)	Oct 30, 2025

Drugs and Companies using TRAMETINIB DIMETHYL SULFOXIDE ingredient

Market Authorisation Date: 29 May, 2013

Treatment: NA

Dosage: TABLET;ORAL

22. List of Onureg 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).
US11571436	BRISTOL	NA	May, 2029 (6 years from now)

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

Drugs and Companies using AZACITIDINE ingredient

Market Authorisation Date: 01 September, 2020

Treatment: NA

Dosage: TABLET;ORAL

23. List of Opzelura 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).
US11571425	INCYTE CORP	NA	May, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
New Product (NP)	Sep 21, 2024
New Indication (I)	Jul 18, 2025
Pediatric Exclusivity (PED)	Mar 21, 2025

Drugs and Companies using RUXOLITINIB PHOSPHATE ingredient

Market Authorisation Date: 21 September, 2021

Treatment: NA

Dosage: CREAM;TOPICAL

24. List of Orkambi 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).
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Strength (NS)	Sep 2, 2025
Orphan Drug Exclusivity (ODE)	Aug 7, 2025
New Patient Population (NPP)	Sep 2, 2025

Drugs and Companies using IVACAFTOR; LUMACAFTOR ingredient

Market Authorisation Date: 07 August, 2018

Treatment: Treatment of cf in a patient age 6 years and older who is homozygous for the f508del mutation in the cftr gene using the composition recited in claim 1 of us 11564916

Dosage: GRANULE;ORAL

25. List of Orserdu 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.
US8399520	STEMLINE THERAP	Selective estrogen receptor modulator	Dec, 2023 (9 months from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10745343	STEMLINE THERAP	Polymorphic forms of RAD1901-2HCl	Jan, 2038 (14 years from now)
US10071066	STEMLINE THERAP	Method of treating cancer using selective estrogen receptor modulators	Oct, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jan 27, 2028

Drugs and Companies using ELACESTRANT DIHYDROCHLORIDE ingredient

NCE-1 date: 2027-01-27

Market Authorisation Date: 27 January, 2023

Treatment: Treatment of an er-positive breast cancer; Treatment of an er-positive breast cancer following at least one line of endocrine therapy

Dosage: TABLET;ORAL

26. List of Prevduo 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).
US10456354	SLAYBACK PHARMA LLC	Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate	Oct, 2038 (15 years from now)
US11110054	SLAYBACK PHARMA LLC	Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate	Oct, 2038 (15 years from now)

Drugs and Companies using GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE ingredient

Market Authorisation Date: 23 February, 2023

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

27. 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).
US11576903	DECIPHERA PHARMS	NA	Dec, 2040 (17 years from now)
US11576904	DECIPHERA PHARMS	NA	Aug, 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: 2024-05-15

Market Authorisation Date: 15 May, 2020

Treatment: Treatment of gastrointestinal stromal tumors in patients suffering from grade 2 or grade 3 arthralgia while being administered ripretinib daily

Dosage: TABLET;ORAL

28. List of Qvar Redihaler 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).
US11559637	NORTON WATERFORD	Inhalers and related methods	Jul, 2039 (16 years from now)

Drugs and Companies using BECLOMETHASONE DIPROPIONATE ingredient

Market Authorisation Date: 03 August, 2017

Treatment: NA

Dosage: AEROSOL, METERED;INHALATION

29. List of Relyvrio 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).
US11583542	AMYLYX	NA	Jul, 2040 (17 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Sep 29, 2027

Drugs and Companies using SODIUM PHENYLBUTYRATE; TAURURSODIOL ingredient

NCE-1 date: 2026-09-29

Market Authorisation Date: 29 September, 2022

Treatment: NA

Dosage: FOR SUSPENSION;ORAL

30. List of Sunosi 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).
US11560354	AXSOME MALTA	Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof	Mar, 2039 (15 years from now)
US11160779	AXSOME MALTA	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: 2023-06-18

Market Authorisation Date: 17 June, 2019

Treatment: Treatment of excessive daytime sleepiness by adminstering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane; Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment

Dosage: TABLET;ORAL

31. List of Symdeko (copackaged) 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).
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2027
New Chemical Entity Exclusivity (NCE)	Feb 12, 2023

Drugs and Companies using IVACAFTOR; IVACAFTOR, TEZACAFTOR ingredient

NCE-1 date: 2022-02-12

Market Authorisation Date: 12 February, 2018

Treatment: Treatment of cf in a patient age 6 years and older who is homozygous for f508del or has at least one cftr gene mutation responsive to tez/iva based on in vitro data and/or clinical evidence using the composition recited in us 11564916 claim 1

Dosage: TABLET;ORAL

32. List of Synjardy 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).
US9949997	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	May, 2034 (11 years from now)

Drugs and Companies using EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ingredient

Market Authorisation Date: 26 August, 2015

Treatment: Method for reducing the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus by once daily administration of empagliflozin; Method for reducing the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease by once daily administration of io mg or 25 mg of empagliflozin

Dosage: TABLET;ORAL

SYNJARDY family patents

United States

Japan

China

Israel

Philippines

Korea, Republic of

Canada

Australia

European Union

Portugal

Spain

Croatia

New Zealand

Mexico

Hong Kong

Lithuania

Poland

Chile

Finland

Denmark

33. List of Synjardy Xr 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).
US9949997	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	May, 2034 (11 years from now)

Drugs and Companies using EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ingredient

Market Authorisation Date: 09 December, 2016

Dosage: TABLET, EXTENDED RELEASE;ORAL

SYNJARDY XR family patents

United States

Japan

China

Israel

Philippines

Korea, Republic of

Canada

Australia

European Union

Portugal

Spain

Croatia

New Zealand

Mexico

Hong Kong

Lithuania

Poland

Chile

Finland

Denmark

34. List of Tafinlar 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).
US7994185 (Pediatric)	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	Jul, 2030 (7 years from now)
US8415345 (Pediatric)	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	Jul, 2030 (7 years from now)
US9233956 (Pediatric)	NOVARTIS	Benzene sulfonamide thiazole and oxazole compounds	Nov, 2029 (6 years from now)
US8952018 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Apr, 2031 (8 years from now)
US8835443 (Pediatric)	NOVARTIS	Pyrimidine compound and medical use thereof	Dec, 2025 (2 years from now)
US8703781 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors	Apr, 2031 (8 years from now)
US10869869 (Pediatric)	NOVARTIS	Method of adjuvant cancer treatment	Mar, 2034 (10 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jun 22, 2024
New Indication (I)	Jun 22, 2025
Pediatric Exclusivity (PED)	Oct 30, 2025

Drugs and Companies using DABRAFENIB MESYLATE ingredient

Market Authorisation Date: 29 May, 2013

Treatment: NA

Dosage: CAPSULE;ORAL

35. List of Tlando 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).
US11559530	ANTARES PHARMA INC	Oral testosterone undecanoate therapy	Nov, 2037 (14 years from now)

Exclusivity	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 hypogonadism (congenital or acquired).

Dosage: CAPSULE;ORAL

36. List of Trijardy Xr 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).
US11564886	BOEHRINGER INGELHEIM	Pharmaceutical compositions	Mar, 2032 (8 years from now)

Drugs and Companies using EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE ingredient

Market Authorisation Date: 27 January, 2020

Treatment: Treatment of a type 2 diabetes patient with insufficient glycemic control despite metformin therapy using a composition comprising and extended release core comprising metformin and an outer coating comprising empagliflozin and linagliptin

Dosage: TABLET, EXTENDED RELEASE;ORAL

37. List of Trikafta (copackaged) 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).
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Patient Population (NPP)	Jun 8, 2024
New Chemical Entity Exclusivity (NCE)	Oct 21, 2024
Orphan Drug Exclusivity (ODE)	Dec 21, 2027

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

NCE-1 date: 2023-10-22

Market Authorisation Date: 21 October, 2019

Treatment: Treatment of cf in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data by administering the composition recited in us 11564916 claim 1

Dosage: TABLET;ORAL

38. List of Xelstrym 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).
US11559501	NOVEN PHARMS INC	Transdermal amphetamine compositions with low levels of carbamate	Jan, 2042 (18 years from now)

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

Drugs and Companies using DEXTROAMPHETAMINE ingredient

Market Authorisation Date: 22 March, 2022

Treatment: NA

Dosage: SYSTEM;TRANSDERMAL

39. List of Xhance 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).
US11554229	OPTINOSE US INC	Nasal administration	Feb, 2036 (12 years from now)

Drugs and Companies using FLUTICASONE PROPIONATE ingredient

Market Authorisation Date: 18 September, 2017

Treatment: Method of delivering fluticasone propionate to a nasal airway

Dosage: SPRAY, METERED;NASAL

40. List of Zimhi 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).
US11571518	ADAMIS PHARMS CORP	NA	Jun, 2041 (18 years from now)

Drugs and Companies using NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 15 October, 2021

Treatment: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device; A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a needle guard; A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a window configured to allow the user to view the opioid antagonist in the syringe

Dosage: SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

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Drugs expiring in 2023

Drug information about Viekira Xr

Strength	Dosage	Availability
EQ 4MG BASE	CAPSULE;ORAL	Prescription
EQ 10MG BASE	CAPSULE;ORAL	Prescription

Strength	Dosage	Availability
EQ 0.5MG	TABLET;ORAL	Prescription
EQ 1MG	TABLET;ORAL	Discontinued
EQ 2MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
94MG/PACKET;75MG/PACKET	GRANULE;ORAL	Prescription
125MG/PACKET;100MG/PACKET	GRANULE;ORAL	Prescription
188MG/PACKET;150MG/PACKET	GRANULE;ORAL	Prescription

Strength	Dosage	Availability
EQ 86MG BASE	TABLET;ORAL	Prescription
EQ 345MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
0.04MG/INH	AEROSOL, METERED;INHALATION	Prescription
0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription

Strength	Dosage	Availability
EQ 75MG BASE	TABLET;ORAL	Prescription
EQ 150MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
75MG;75MG, 50MG	TABLET;ORAL	Prescription
150MG;150MG, 100MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
5MG;1GM	TABLET;ORAL	Prescription
5MG;500MG	TABLET;ORAL	Prescription
12.5MG;1GM	TABLET;ORAL	Prescription
12.5MG;500MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 50MG BASE	CAPSULE;ORAL	Prescription
EQ 75MG BASE	CAPSULE;ORAL	Prescription

Strength	Dosage	Availability
5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
10MG;5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
12.5MG;2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
25MG;5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription

Strength	Dosage	Availability
50MG,37.5MG,25MG; 75MG	TABLET;ORAL	Prescription
100MG,75MG,50MG; 150MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
4.5MG/9HR	SYSTEM;TRANSDERMAL	Prescription
9MG/9HR	SYSTEM;TRANSDERMAL	Prescription
13.5MG/9HR	SYSTEM;TRANSDERMAL	Prescription
18MG/9HR	SYSTEM;TRANSDERMAL	Prescription

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