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Finasteride - Generic Drug Details

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

This ingredient has six patent family members in five countries.

There are fourteen drug master file entries for finasteride. Thirty-nine suppliers are listed for this compound.

Summary for Generic Name: finasteride

Tradenames:3
Patents:1
Applicants:17
NDAs:22
Drug Master File Entries: see list14
Suppliers / Packaging: see list39
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Drug Prices:see low prices

Pharmacology for Ingredient: finasteride

Clinical Trials for: finasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 1997RXYes
Teva
FINASTERIDE
finasteride
TABLET;ORAL076905-001Nov 5, 2013RXNo
Hetero Labs Ltd Iii
FINASTERIDE
finasteride
TABLET;ORAL090060-001Jul 1, 2013RXNo
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Expired Orange Book Patents for Generic Ingredient: finasteride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19924,377,584<disabled>
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 19975,571,817<disabled>
Merck
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 19975,886,184<disabled>
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International Patent Family for Ingredient: finasteride

Country Document Number Estimated Expiration
Australia1279099<disabled in preview>
European Patent Office1032400<disabled in preview>
Canada2308070<disabled in preview>
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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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