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Pirfenidoneis 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 sixty-four 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 are five tentative approvals for this compound.
Summary for pirfenidone
|Drug Master File Entries:||23|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||124|
|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
|parkview cancer institute||Phase 1/Phase 2|
|University of Kansas Medical Center||Phase 1/Phase 2|
|Blade Therapeutics||Phase 1|
Generic filers with tentative approvals for PIRFENIDONE
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
|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||208780-003||Jan 11, 2017||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|Genentech Inc||ESBRIET||pirfenidone||TABLET;ORAL||208780-001||Jan 11, 2017||RX||Yes||No||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|Genentech Inc||ESBRIET||pirfenidone||CAPSULE;ORAL||022535-001||Oct 15, 2014||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|Genentech Inc||ESBRIET||pirfenidone||TABLET;ORAL||208780-002||Jan 11, 2017||DISCN||Yes||No||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Country||Patent Number||Estimated Expiration|
|Hong Kong||1151725||⤷ Try it Free|
|Eurasian Patent Organization||200800881||⤷ Try it Free|
|Morocco||32880||⤷ Try it Free|
|Norway||345131||⤷ Try it Free|
|>Country||>Patent Number||>Estimated Expiration|
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