ESBRIET Drug Patent Profile
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Which patents cover Esbriet, and when can generic versions of Esbriet launch?
Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. There are twenty patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and sixty-three patent family members in forty-five countries.
The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Esbriet
A generic version of ESBRIET was approved as pirfenidone by AMNEAL on January 3rd, 2022.
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Questions you can ask:
- What is the 5 year forecast for ESBRIET?
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Summary for ESBRIET
International Patents: | 263 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 19 |
Patent Applications: | 5,625 |
Drug Prices: | Drug price information for ESBRIET |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESBRIET |
What excipients (inactive ingredients) are in ESBRIET? | ESBRIET excipients list |
DailyMed Link: | ESBRIET at DailyMed |


Recent Clinical Trials for ESBRIET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Excalibur Pharmaceuticals, Inc. | Phase 1 |
University of California, San Diego | Phase 2 |
San Diego Veterans Healthcare System | Phase 2 |
Pharmacology for ESBRIET
Drug Class | Pyridone |
Paragraph IV (Patent) Challenges for ESBRIET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ESBRIET | Capsules | pirfenidone | 267 mg | 022535 | 9 | 2018-10-15 |
ESBRIET | Tablets | pirfenidone | 534 mg | 208780 | 2 | 2018-10-15 |
US Patents and Regulatory Information for ESBRIET
ESBRIET is protected by sixty-four US patents.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | AB | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ESBRIET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-002 | Jan 11, 2017 | ⤷ Try for Free | ⤷ Try for Free |
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | ⤷ Try for Free | ⤷ Try for Free |
Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-003 | Jan 11, 2017 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ESBRIET
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Esbriet | pirfenidone | EMEA/H/C/002154 Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis. |
Authorised | no | no | no | 2011-02-27 | |
Axunio Pharma GmbH | Pirfenidone axunio (previously Pirfenidone AET) | pirfenidone | EMEA/H/C/005873 Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). |
Authorised | yes | no | no | 2022-06-20 | |
Viatris Limited | Pirfenidone Viatris | pirfenidone | EMEA/H/C/005862 Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). |
Authorised | yes | no | no | 2023-01-10 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ESBRIET
When does loss-of-exclusivity occur for ESBRIET?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 55
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Argentina
Patent: 7990
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 06295440
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 11201520
Patent: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients
Estimated Expiration: ⤷ Try for Free
Patent: 13201986
Patent: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients
Estimated Expiration: ⤷ Try for Free
Patent: 14240300
Patent: Capsule Formulation of Pirfenidone and Pharmaceutically Acceptable Excipients
Estimated Expiration: ⤷ Try for Free
Patent: 17241530
Estimated Expiration: ⤷ Try for Free
Patent: 22275529
Patent: Granulate formulation of 5-methyl-1-phenyl-2(1H)-pyridone and method of making the same
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0616324
Patent: formulaÇço de cÁpsula de pirfenidona e excipientes farmaceuticamente aceitÁveis
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 20380
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Patent: 62013
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Patent: 37365
Patent: FORMULATION EN GRANULES DE 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE ET METHODE DE FABRICATION ASSOCIEE (GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Try for Free
China
Patent: 1267810
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 3393607
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 3735530
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 8883072
Patent: 5-甲基-1-苯基-2-(1H)-吡啶酮颗粒制剂和其制备方法 (GRANULATE FORMULATION OF 5-METHY-1-PHENY-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Try for Free
Patent: 4533688
Patent: 5-甲基-1-苯基-2-(1H)-吡啶酮颗粒制剂和其制备方法 (5-methyl-1-phenyl-2-(1H)-pyridone granular formulations and processes for their preparation)
Estimated Expiration: ⤷ Try for Free
Cuba
Patent: 080043
Patent: FORMULACIÓN DE CÁPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACÉUTICAMENTE ACEPTABLES
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 15544
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 40364
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 088394
Patent: FORMULACIÓN DE CÁPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACÉUTICAMENTE ACEPTABLES
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 0093
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Patent: 0800881
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 40364
Patent: CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Patent: 31025
Patent: Formulation de capsule de pirfénidone et excipients pharmaceutiquement acceptables (Capsule formulation of pirfenidone and pharmaceutically acceptable excipients)
Estimated Expiration: ⤷ Try for Free
Patent: 35985
Patent: PRÉPARATION DE GRANULÉS DE 5-MÉTHYL-1-PHÉNYL-2(1H)-PYRIDONE ET SON PROCÉDÉ DE FABRICATION (GRANULATE FORMULATION OF 5-METHY!-1-PHENY!-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Try for Free
Patent: 95696
Patent: PRÉPARATION DE GRANULÉS DE 5-MÉTHYL-1-PHÉNYL-2(1H)-PYRIDONE ET SON PROCÉDÉ DE FABRICATION (GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Try for Free
Georgia, Republic of
Patent: 0115303
Patent: CAPSULE OF PIRFENIDONE
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 17762
Patent: 吡非尼酮與藥學上可接受的賦形劑的膠囊製劑 (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 9273
Patent: תצורה קפסולרית של פירפנידון וחומרי תרופה בלתי-פעילים המתאימים מבחינה פרמצבטית (Capsule formulation of pirfenidone and pharmaceutically acceptable excipients)
Estimated Expiration: ⤷ Try for Free
Patent: 1745
Patent: פורמולציית גרגירים של 5-מתיל-1-פניל-2(h1)-פירידון ושיטה להכנתה (Granulate formulation of 5-methyl-1-phenyl-2(1h)-pyridone and method of making the same)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 15101
Estimated Expiration: ⤷ Try for Free
Patent: 37732
Estimated Expiration: ⤷ Try for Free
Patent: 56721
Estimated Expiration: ⤷ Try for Free
Patent: 09509962
Estimated Expiration: ⤷ Try for Free
Patent: 12224641
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENT
Estimated Expiration: ⤷ Try for Free
Patent: 14169341
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Try for Free
Patent: 19513145
Patent: 5−メチル−1−フェニル−2−(1H)−ピリドンの顆粒製剤及びその製造方法
Estimated Expiration: ⤷ Try for Free
Patent: 22087115
Patent: 5-メチル-1-フェニル-2-(1H)-ピリドンの顆粒製剤及びその製造方法
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 08003882
Patent: FORMULACION DE CAPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACEUTICAMENTE ACEPTABLES. (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS.)
Estimated Expiration: ⤷ Try for Free
Patent: 18011819
Patent: FORMULACION GRANULADA DE 5-METIL-1-FENIL-2-(1H)-PIRIDONA Y METODO PARA ELABORARLA. (GRANULATE FORMULATION OF 5-METHY|-1-PHENY|-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME.)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 875
Patent: FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 5957
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 1443
Patent: Granule formation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Patent: 0129
Patent: Capsule formation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 5131
Estimated Expiration: ⤷ Try for Free
Patent: 080759
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 40364
Estimated Expiration: ⤷ Try for Free
Patent: 35985
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 40364
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 40364
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 0802237
Patent: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1645069
Estimated Expiration: ⤷ Try for Free
Patent: 1675651
Estimated Expiration: ⤷ Try for Free
Patent: 2552615
Estimated Expiration: ⤷ Try for Free
Patent: 080046673
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Try for Free
Patent: 130100381
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Try for Free
Patent: 140029554
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Try for Free
Patent: 180123067
Patent: 5-메틸-1-페닐-2-(1H)-피리돈의 과립화 제형 및 이의 제조 방법
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 96144
Estimated Expiration: ⤷ Try for Free
Patent: 83595
Estimated Expiration: ⤷ Try for Free
Tunisia
Patent: 08136
Patent: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 433
Patent: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ;ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Estimated Expiration: ⤷ Try for Free
Patent: 5861
Patent: ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ESBRIET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1145138 | MODIFYING PIRFENIDONE TREATMENT FOR PATIENTS WITH ATYPICAL LIVER FUNCTION | ⤷ Try for Free |
South Korea | 101675651 | ⤷ Try for Free | |
Japan | 2012153734 | PIRFENIDONE THERAPY AND INDUCER OF CYTOCHROME P450 | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Esbriet (Pirfenidone)
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