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, Laurus, Sandoz Inc, Sciegen Pharms Inc, Aizant, Alembic Pharms, 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. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for pirfenidone

International Patents:	272
US Patents:	21
Tradenames:	2
Applicants:	12
NDAs:	18
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	113
Patent Applications:	6,243
Formulation / Manufacturing:	see details
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

Recent Clinical Trials for pirfenidone

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

Sponsor	Phase
Fujian Medical University Union Hospital	Phase 2
Bridge Biotherapeutics, Inc.	Phase 2
Simbec Research	Phase 2

See all pirfenidone clinical trials

Generic filers with tentative approvals for PIRFENIDONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	801MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	267MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	267MG	CAPSULE;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

Anatomical Therapeutic Chemical (ATC) Classes for pirfenidone

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
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	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz Inc	PIRFENIDONE	pirfenidone	TABLET;ORAL	212560-001	Apr 28, 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

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	⤷ 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

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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 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

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Country	Patent Number	Title	Estimated Expiration
San Marino	T201200009	Terapia con pirfenidone che evita la fluvoxamina	⤷ Sign Up
Japan	2019513145	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	⤷ Sign Up
Chile	2011000966	Uso de pirfenidona para preparar un medicamento util para tratar un paciente que se beneficiara de su administracion, donde dicho paciente ha exxhibido una anormalidad grado 2 en una o ambas transaminasa alamina (alt) o transaminasa aspartato (ast), despues de la administracion de pirfenidona.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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