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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Baxter
Queensland Health
Healthtrust
QuintilesIMS
McKinsey
Citi
Colorcon
Fish and Richardson

Generated: June 28, 2017

DrugPatentWatch Database Preview

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 are two patents 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 suppliers are listed for this compound.

Summary for Generic Name: finasteride

Tradenames:3
Patents:2
Applicants:18
NDAs:24
Drug Master File Entries: see list14
Suppliers / Packagers: see list40
Bulk Api Vendors: see list64
Clinical Trials: see list63
Patent Applications: see list5,573
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
Aurobindo Pharma Ltd
FINASTERIDE
finasteride
TABLET;ORAL203687-001Nov 5, 2013ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
FINASTERIDE
finasteride
TABLET;ORAL078161-001Nov 5, 2013ABRXNoNo► Subscribe► Subscribe
Accord Hlthcare
FINASTERIDE
finasteride
TABLET;ORAL090121-001Feb 23, 2010ABRXNoNo► Subscribe► Subscribe
Hetero Labs Ltd Iii
FINASTERIDE
finasteride
TABLET;ORAL090060-001Jul 1, 2013ABRXNoNo► Subscribe► Subscribe
Teva
FINASTERIDE
finasteride
TABLET;ORAL076905-001Nov 5, 2013ABRXNoNo► 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
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19926,046,183► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 19974,760,071► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19924,377,584► Subscribe
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19925,886,184► Subscribe
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 19975,547,957► Subscribe
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International Patent Family for Ingredient: finasteride

Country Document Number Estimated Expiration
Japan2001521000► Subscribe
Canada2308070► Subscribe
World Intellectual Property Organization (WIPO)9921563► Subscribe
Australia731576► Subscribe
European Patent Office1032400► 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 500+ biopharmaceutical companies globally:

Cipla
McKinsey
Moodys
Deloitte
Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
Chinese Patent Office
Mallinckrodt
Medtronic

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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