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Last Updated: January 30, 2023

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, Laurus, Sandoz Inc, Sciegen Pharms Inc, Aizant, Alembic Pharms Ltd, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in eighteen NDAs. There are twenty-one 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 seventy-two patent family members in forty-five countries.

There are twenty-three drug master file entries for pirfenidone. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for pirfenidone

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

SponsorPhase
Bridge Biotherapeutics, Inc.Phase 2
Redx Pharma PlcPhase 2
Simbec ResearchPhase 2

See all pirfenidone clinical trials

Generic filers with tentative approvals for PIRFENIDONE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing801MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing267MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing267MGCAPSULE;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
Aizant PIRFENIDONE pirfenidone TABLET;ORAL 212747-001 Jul 21, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn PIRFENIDONE pirfenidone TABLET;ORAL 212772-002 May 24, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 See Plans and Pricing See Plans and Pricing
>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 mild to moderate 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 pirfenidone

Country Patent Number Title Estimated Expiration
Ecuador SP088394 FORMULACIÓN DE CÁPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACÉUTICAMENTE ACEPTABLES See Plans and Pricing
Australia 2011201462 Method of Administering Pirfenidone Therapy See Plans and Pricing
Austria 503480 See Plans and Pricing
Slovenia 2343070 See Plans and Pricing
Tunisia 2011000217 PIRFENIDONE TREATMENT FOR PATIENTS WITH ATYPICAL LIVER FUCTION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.