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Serving leading biopharmaceutical companies globally:

McKinsey
Daiichi Sankyo
Baxter
Colorcon
Mallinckrodt
US Army
Fuji
Chubb
Harvard Business School
QuintilesIMS

Generated: November 23, 2017

DrugPatentWatch Database Preview

Pirfenidone - Generic Drug Details

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What are the generic drug sources for pirfenidone and what is the scope of pirfenidone patent protection?

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

Pirfenidone has two hundred and forty patent family members in forty-one countries.

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

Pharmacology for pirfenidone

Ingredient-typePyridones
Drug ClassPyridone
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;ORAL022535-001Oct 15, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-002Jan 11, 2017DISCNYesNo► Subscribe► Subscribe► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-003Jan 11, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-003Jan 11, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-003Jan 11, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-003Jan 11, 2017RXYesYes► Subscribe► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
CAPSULE;ORAL022535-001Oct 15, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Genentech Inc
ESBRIET
pirfenidone
TABLET;ORAL208780-003Jan 11, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pirfenidone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,867,516Medicinal preparation containing 5-methyl-1-phenyl-2-(1h)-pyridone as active ingredient► Subscribe
9,017,722Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pirfenidone

Country Document Number Estimated Expiration
Georgia, Republic ofP201706719► Subscribe
Australia2013204049► Subscribe
Georgia, Republic ofP20166455► Subscribe
Japan2015526528► Subscribe
Germany60234812► Subscribe
World Intellectual Property Organization (WIPO)2011069094► Subscribe
Mexico2008003882► Subscribe
Australia2013308489► Subscribe
Hong Kong1151725► Subscribe
World Intellectual Property Organization (WIPO)2008077068► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Merck
McKesson
Express Scripts
Johnson and Johnson
Deloitte
Novartis
Accenture
McKinsey

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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