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Serving leading biopharmaceutical companies globally:

Accenture
Cerilliant
Fish and Richardson
Johnson and Johnson
Queensland Health
Federal Trade Commission
Colorcon
QuintilesIMS
Express Scripts
Novartis

Generated: October 20, 2017

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Finasteride - Generic Drug Details

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

Finasteride
is the generic ingredient in three branded drugs marketed by Zydus Pharms Usa Inc, Alkem Labs Ltd, Teva, Sun Pharma Global, Actavis Totowa Teva, Accord Hlthcare, Cipla Ltd, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Aurobindo Pharma, Gedeon Richter Usa, Hetero Labs Ltd Iii, Mylan Pharms Inc, Actavis Totowa, Mylan, Merck, and Aurobindo Pharma Ltd, and is included in twenty-four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Finasteride has six patent family members in five countries.

There are fourteen drug master file entries for finasteride. Forty-two suppliers are listed for this compound.

Summary for Generic Name: finasteride

US Patents:1
Tradenames:3
Applicants:18
NDAs:24
Drug Master File Entries: see list14
Suppliers / Packagers: see list42
Bulk Api Vendors: see list68
Clinical Trials: see list63
Patent Applications: see list6,912
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:finasteride at DailyMed

Pharmacology for Ingredient: finasteride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd
FINASTERIDE
finasteride
TABLET;ORAL207750-001Jan 6, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
FINASTERIDE
finasteride
TABLET;ORAL076340-001Jun 19, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Totowa Teva
FINASTERIDE
finasteride
TABLET;ORAL077914-001Mar 28, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
FINASTERIDE
finasteride
TABLET;ORAL076436-001Jul 28, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
FINASTERIDE
finasteride
TABLET;ORAL078900-001Dec 28, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma Global
FINASTERIDE
finasteride
TABLET;ORAL090507-001Aug 16, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
FINASTERIDE
finasteride
TABLET;ORAL077335-001Nov 20, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd Iii
FINASTERIDE
finasteride
TABLET;ORAL090061-001Jun 7, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
FINASTERIDE
finasteride
TABLET;ORAL203687-001Nov 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: finasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997► Subscribe► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992► Subscribe► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997► Subscribe► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997► Subscribe► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992► Subscribe► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992► Subscribe► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997► Subscribe► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992► Subscribe► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: finasteride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9921563► Subscribe
Australia1279099► Subscribe
European Patent Office1032400► Subscribe
Canada2308070► Subscribe
Australia731576► Subscribe
Japan2001521000► 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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Serving leading biopharmaceutical companies globally:

Teva
McKesson
McKinsey
Cantor Fitzgerald
Express Scripts
Farmers Insurance
Boehringer Ingelheim
Federal Trade Commission
QuintilesIMS
Colorcon

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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