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Pirfenidone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pirfenidone?

Pirfenidone is the generic ingredient in one branded drug marketed by Genentech Inc and is included in two NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eighty-nine patent family members in forty countries.

There are seven drug master file entries for pirfenidone. Two suppliers are listed for this compound.

Summary for Generic Name: pirfenidone

Tradenames:1
Patents:20
Applicants:1
NDAs:2
Drug Master File Entries: see list7
Suppliers / Packagers: see list2
Bulk Api Vendors: see list90
Clinical Trials: see list23
Patent Applications: see list1,652
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pirfenidone at DailyMed

Pharmacology for Ingredient: pirfenidone

Ingredient-typePyridones
Drug ClassPyridone
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes7,696,236► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes8,753,679► SubscribeY ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes8,084,475► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes8,609,701► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-002Jan 11, 2017DISCNYesNo► Subscribe► Subscribe
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International Patent Family for Ingredient: pirfenidone

Country Document Number Estimated Expiration
Japan2012532934► Subscribe
Morocco32880► Subscribe
TaiwanI419877► Subscribe
European Patent Office2441455► Subscribe
World Intellectual Property Organization (WIPO)2007038315► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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