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Last Updated: April 19, 2024

PIRFENIDONE - Generic Drug Details

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What are the generic sources for pirfenidone and what is the scope of freedom to operate?

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-two 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.

Summary for PIRFENIDONE

International Patents:	262
US Patents:	20
Tradenames:	2
Applicants:	14
NDAs:	22
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	116
Patent Applications:	6,743
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for PIRFENIDONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PIRFENIDONE
What excipients (inactive ingredients) are in PIRFENIDONE?	PIRFENIDONE excipients list
DailyMed Link:	PIRFENIDONE at DailyMed

See drug prices for PIRFENIDONE

Recent Clinical Trials for PIRFENIDONE

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

Sponsor	Phase
Pulmongene Ltd.	Phase 1
Hubei Cancer Hospital	Phase 2
Fujian Medical University Union Hospital	Phase 2

See all PIRFENIDONE clinical trials

Generic filers with tentative approvals for PIRFENIDONE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	801MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	267MG	TABLET;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 Class	Pyridone

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	PIRFENIDONE	pirfenidone	TABLET;ORAL	212680-001	May 18, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	PIRFENIDONE	pirfenidone	TABLET;ORAL	212709-001	May 31, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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

EU/EMA Drug Approvals for PIRFENIDONE

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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 PIRFENIDONE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3895696	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)	⤷ Try a Trial
Spain	2578715		⤷ Try a Trial
Brazil	112012014108	métodos para administração terapia de pirfenidona.	⤷ Try a Trial
China	105168210	Methods of administering pirfenidone therapy	⤷ Try a Trial
South Korea	101762465		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2008077068		⤷ Try a Trial
Eurasian Patent Organization	026869	СПОСОБ ЛЕЧЕНИЯ ИДИОПАТИЧЕСКОГО ЛЕГОЧНОГО ФИБРОЗА (METHOD OF TREATING IDIOPATHIC PULMONARY FIBROSIS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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