PIRFENIDONE Drug Patent Profile
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Which patents cover Pirfenidone, and when can generic versions of Pirfenidone launch?
Pirfenidone is a drug marketed by Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, Sandoz, Sciegen Pharms Inc, Aizant, Alembic, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa. and is included in twenty NDAs.
The generic ingredient in PIRFENIDONE 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 Pirfenidone
A generic version of PIRFENIDONE was approved as pirfenidone by AMNEAL on January 3rd, 2022.
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Summary for PIRFENIDONE
Recent Clinical Trials for PIRFENIDONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nanfang Hospital, Southern Medical University | Phase 2 |
| Boehringer Ingelheim | Phase 1 |
| Modern Biosciences Ltd | Phase 2 |
Pharmacology for PIRFENIDONE
| Drug Class | Pyridone |
Anatomical Therapeutic Chemical (ATC) Classes for PIRFENIDONE
Paragraph IV (Patent) Challenges for PIRFENIDONE
| 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 PIRFENIDONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sciegen Pharms Inc | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212078-001 | Aug 1, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Msn | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212772-001 | May 24, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sciegen Pharms Inc | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212078-002 | Aug 1, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Msn | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212772-002 | May 24, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Accord Hlthcare | PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212731-001 | Jan 20, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212709-002 | May 31, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Laurus | PIRFENIDONE | pirfenidone | TABLET;ORAL | 212722-002 | Jul 19, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for PIRFENIDONE
| 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 |
