Pharsight

1. Cotellic patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13753131A	2020-03-24	Sandoz AG	Opposition rejected
EP06825554A	2012-01-05	EIP Limited	Opposition rejected

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.
US7803839	GENENTECH INC	Azetidines as MEK inhibitors for the treatment of proliferative diseases	Nov, 2029 (5 years from now)
US10478400	GENENTECH INC	Immediate-release tablets containing combimetinib and methods of making and using the same	Jun, 2036 (12 years from now)
US11254649	GENENTECH INC	Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone	Jun, 2036 (12 years from now)
US10590102	GENENTECH INC	Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone	Jun, 2036 (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).
US8362002	GENENTECH INC	Azetidines as MEK inhibitors for the treatment of proliferative diseases	Oct, 2026 (2 years from now)
US11597699	GENENTECH INC	MEK inhibitors and methods of their use	Oct, 2026 (2 years from now)
US8362002 (Pediatric)	GENENTECH INC	Azetidines as MEK inhibitors for the treatment of proliferative diseases	Apr, 2027 (2 years from now)
US7803839 (Pediatric)	GENENTECH INC	Azetidines as MEK inhibitors for the treatment of proliferative diseases	May, 2030 (6 years from now)
US11087354	GENENTECH INC	Combination therapies	Jun, 2034 (10 years from now)
US11087354 (Pediatric)	GENENTECH INC	Combination therapies	Dec, 2034 (10 years from now)
US10478400 (Pediatric)	GENENTECH INC	Immediate-release tablets containing combimetinib and methods of making and using the same	Dec, 2036 (12 years from now)
US11254649 (Pediatric)	GENENTECH INC	Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone	Dec, 2036 (12 years from now)
US10590102 (Pediatric)	GENENTECH INC	Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone	Dec, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-902)	Oct 28, 2025
M(M-278)	Jul 28, 2025
Orphan Drug Exclusivity(ODE-416)	Oct 28, 2029
Pediatric Exclusivity(PED)	Jan 28, 2026
Orphan Drug Exclusivity(ODE-101)	Nov 10, 2022
New Chemical Entity Exclusivity(NCE)	Nov 10, 2020
Orphan Drug Exclusivity(ODE)	Nov 10, 2022

Drugs and Companies using COBIMETINIB FUMARATE ingredient

NCE-1 date: 28 January, 2025

Market Authorisation Date: 10 November, 2015

Treatment: Method of using cobimetinib for the treatment of melanoma; As a single agent for the treatment of adult patients with histiocytic neoplasms

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 20MG BASE	TABLET;ORAL	Prescription

COTELLIC family patents

2. Esbriet patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP16151564A	2022-03-30	Zentiva k.s.	Granted and Under Opposition
EP16151564A	2022-03-29	STADA Arzneimittel AG	Granted and Under Opposition
EP16151564A	2022-03-29	Generics [UK] Limited	Granted and Under Opposition
EP16151564A	2022-03-28	Aera A/S	Granted and Under Opposition
EP17716354A	2022-02-08	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP13176914A	2021-02-19	Intas Pharmaceuticals Ltd.	Granted and Under Opposition
EP13176914A	2021-02-19	Alfred E. Tiefenbacher (GmbH & Co. KG)	Granted and Under Opposition
EP13176914A	2021-02-16	Aera A/S	Granted and Under Opposition
EP10835207A	2021-02-15	Intas Pharmaceuticals Ltd.	Revoked
EP10835207A	2021-02-12	Generics [UK] Limited	Revoked
EP10835207A	2021-02-11	SANDOZ AG	Revoked
EP13176914A	2021-02-10	SANDOZ AG	Granted and Under Opposition
EP10835207A	2021-02-03	Aera A/S	Revoked
EP10835207A	2021-01-26	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP10835207A	2021-01-26	STADA Arzneimittel AG	Revoked
EP13275196A	2017-06-20	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP13275196A	2017-06-20	Sandoz AG	Revoked
EP11002040A	2017-01-27	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP11002040A	2017-01-24	Sandoz AG	Revoked
EP12166074A	2017-01-03	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP12166074A	2016-12-22	Sandoz AG	Revoked
EP11002040A	2016-12-15	ratiopharm GmbH	Revoked
EP12166074A	2016-12-15	ratiopharm GmbH	Revoked
EP11001414A	2015-07-10	Sandoz AG	Revoked
EP06815221A	2015-03-11	Dannenberger, Oliver Andre	Patent maintained as amended
EP10250379A	2012-06-28	Sandoz AG	Revoked

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).
US9561217	GENENTECH INC	Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone	Jan, 2022 (2 years ago)
US8753679	GENENTECH INC	Capsule formulation of pirfenidone and pharmaceutically acceptable excipients	Sep, 2026 (2 years from now)
US7767225	GENENTECH INC	Capsule formulation of pirfenidone and pharmaceutically acceptable excipients	Sep, 2026 (2 years from now)
US7988994	GENENTECH INC	Capsule formulation of pirfenidone and pharmaceutically acceptable excipients	Sep, 2026 (2 years from now)
US8420674	GENENTECH INC	Method of providing pirfenidone therapy to a patient	Dec, 2027 (3 years from now)
US7767700	GENENTECH INC	Method of providing pirfenidone therapy to a patient	Dec, 2027 (3 years from now)
US7696326	GENENTECH INC	Multiple antigen glycopeptide carbohydrate, vaccine comprising the same and use thereof	Dec, 2027 (3 years from now)
US7696236	GENENTECH INC	Method of providing pirfenidone therapy to a patient	Dec, 2027 (3 years from now)
US8383150	GENENTECH INC	Granulate formulation of pirfenidone and pharmaceutically acceptable excipients	May, 2028 (4 years from now)
US7566729	GENENTECH INC	Modifying pirfenidone treatment for patients with atypical liver function	Apr, 2029 (4 years from now)
US8592462	GENENTECH INC	Pirfenidone treatment for patients with atypical liver function	Apr, 2029 (4 years from now)
US8609701	GENENTECH INC	Pirfenidone treatment for patients with atypical liver function	Apr, 2029 (4 years from now)
US7635707	GENENTECH INC	Pirfenidone treatment for patients with atypical liver function	Apr, 2029 (4 years from now)
US7910610	GENENTECH INC	Methods of administering pirfenidone therapy	Jan, 2030 (5 years from now)
US7816383	GENENTECH INC	Methods of administering pirfenidone therapy	Jan, 2030 (5 years from now)
US8754109	GENENTECH INC	Pirfenidone therapy and inducers of cytochrome P450	Jan, 2030 (5 years from now)
US8318780	GENENTECH INC	Methods of administering pirfenidone therapy	Jan, 2030 (5 years from now)
US8084475	GENENTECH INC	Pirfenidone therapy and inducers of cytochrome P450	Jan, 2030 (5 years from now)
US8648098	GENENTECH INC	Pirfenidone therapy and inducers of cytochrome P450	Jan, 2030 (5 years from now)
US8013002	GENENTECH INC	Methods of administering pirfenidone therapy	Jan, 2030 (5 years from now)
US8778947	GENENTECH INC	Methods of administering pirfenidone therapy	Aug, 2033 (9 years from now)
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
Orphan Drug Exclusivity(ODE-77)	Oct 15, 2021
New Chemical Entity Exclusivity(NCE)	Oct 15, 2019
Orphan Drug Exclusivity(ODE)	Oct 15, 2021

Drugs and Companies using PIRFENIDONE ingredient

NCE-1 date: 15 October, 2018

Market Authorisation Date: 11 January, 2017

Treatment: Method of administering pirfenidone capsules to treat a fibrotic condition; Pirfenidone dose escalation regimen for treatment of fibrosis as 801 mg/day for days 1-7 of the regimen, 1602 mg/day for day...

Dosage: TABLET;ORAL

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

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

ESBRIET family patents

3. Evrysdi patents 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.
US9586955	GENENTECH INC	Compounds for treating spinal muscular atrophy	Feb, 2033 (8 years from now)
US9969754	GENENTECH INC	Compounds for treating spinal muscular atrophy	May, 2035 (11 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).
US11827646	GENENTECH INC	Compounds for treating spinal muscular atrophy	Jan, 2036 (11 years from now)
US11534444	GENENTECH INC	Treatment of SMA	Oct, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-334)	Aug 07, 2027
New Chemical Entity Exclusivity(NCE)	Aug 07, 2025
Orphan Drug Exclusivity(ODE-400)	May 27, 2029
New Patient Population(NPP)	May 27, 2025
M(M-270)	Oct 03, 2026

Drugs and Companies using RISDIPLAM ingredient

NCE-1 date: 07 August, 2024

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

EVRYSDI family patents

4. Gavreto patents 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.
US10030005	GENENTECH INC	Inhibitors of RET	Nov, 2036 (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).
US11273160	GENENTECH INC	RET inhibitor for use in treating cancer having a RET alteration	Apr, 2039 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 04, 2025
Orphan Drug Exclusivity(ODE-341)	Dec 01, 2027
Orphan Drug Exclusivity(ODE-340)	Dec 01, 2027
Orphan Drug Exclusivity(ODE-318)	Sep 04, 2027

Drugs and Companies using PRALSETINIB ingredient

NCE-1 date: 04 September, 2024

Market Authorisation Date: 04 September, 2020

Treatment: Treatment of adult patients with metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc) as detected by an fda approved test; Treatment of adult and pediatri...

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
100MG	CAPSULE;ORAL	Prescription

GAVRETO family patents

5. Rozlytrek patents 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.
US9029356	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US8299057	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Mar, 2029 (4 years from now)
US9085565	GENENTECH INC	Process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2033 (9 years from now)
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 (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).
US8673893	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9255087	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9616059	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9085558	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9649306	GENENTECH INC	Treatment of diseases through administration of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2033 (9 years from now)
US10231965	GENENTECH INC	Molecules for administration to ROS1 mutant cancer cells	Feb, 2035 (10 years from now)
US10561651	GENENTECH INC	Methods for treating neuroblastoma	Feb, 2035 (10 years from now)
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 (13 years from now)
US11253515	GENENTECH INC	Pharmaceutical compositions and dosage forms	Jul, 2038 (14 years from now)
US10398693	GENENTECH INC	Pharmaceutical compositions and dosage forms	Jul, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-265)	Aug 15, 2026
New Chemical Entity Exclusivity(NCE)	Aug 15, 2024
Orphan Drug Exclusivity(ODE-313)	Aug 15, 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 ros1-positive non-small cell lung cancer; Treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion; Treatment of neuroblastomas that have a neurotrop...

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
100MG	CAPSULE;ORAL	Prescription
200MG	CAPSULE;ORAL	Prescription

ROZLYTREK family patents

6. Xofluza patents 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.
US8987441	GENENTECH INC	Substituted polycyclic carbamoyl pyridone derivative prodrug	Sep, 2031 (7 years from now)
US10392406	GENENTECH INC	Substituted polycyclic pyridone derivatives and prodrugs thereof	Apr, 2036 (12 years from now)
US10759814	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 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).
US9815835	GENENTECH INC	Substituted polycyclic carbamolypyridone derivative	Jun, 2030 (6 years from now)
US8927710	GENENTECH INC	Substituted polycyclic carbamoylpyridone derivative	May, 2031 (7 years from now)
US10633397	GENENTECH INC	Substituted polycyclic pyridone derivatives and prodrugs thereof	Apr, 2036 (12 years from now)
US11306106	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 2037 (13 years from now)
US11261198	GENENTECH INC	Process for preparing substituted polycyclic pyridone derivative and crystal thereof	Sep, 2038 (14 years from now)

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

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;ORAL; FOR SUSPENSION;ORAL