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Last Updated: May 29, 2024

Pirfenidone - Generic Drug Details


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What are the generic drug sources for pirfenidone and what is the scope of patent protection?

Pirfenidone is the generic ingredient in two branded drugs marketed by Genentech Inc, 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-two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pirfenidone has two hundred and sixty-three patent family members in forty-five countries.

There are twenty-three drug master file entries for pirfenidone. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for pirfenidone

See drug prices for pirfenidone

Recent Clinical Trials for pirfenidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Pulmongene Ltd.Phase 1
Hubei Cancer HospitalPhase 2
Fujian Medical University Union HospitalPhase 2

See all pirfenidone clinical trials

Generic filers with tentative approvals for PIRFENIDONE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up801MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up267MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pirfenidone
Drug ClassPyridone
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
Laurus PIRFENIDONE pirfenidone TABLET;ORAL 212722-001 Jul 19, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Amneal PIRFENIDONE pirfenidone TABLET;ORAL 212570-002 Mar 25, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes 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

Expired US Patents for pirfenidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 ⤷  Sign Up ⤷  Sign Up
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

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