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Last Updated: July 6, 2020

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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 one branded drug marketed by Genentech Inc and is included in two 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 fifty-nine patent family members in forty-five countries.

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

Recent Clinical Trials for pirfenidone

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 3
Pulmonary Fibrosis FoundationPhase 3
University of VirginiaPhase 3

See all pirfenidone clinical trials

Generic filers with tentative approvals for PIRFENIDONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial267MGCAPSULE;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 NDA Submissiondate
ESBRIET CAPSULE;ORAL pirfenidone 022535 2018-10-15
ESBRIET TABLET;ORAL pirfenidone 208780 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
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Dow
Colorcon
Harvard Business School
McKinsey

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