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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)
Formulation / Manufacturing:see details

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
Accord Hlthcare
FINASTERIDE
finasteride
TABLET;ORAL090121-001Feb 23, 2010RXNo<disabled><disabled>
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 1992RXYes5,942,519<disabled> <disabled>
Teva
FINASTERIDE
finasteride
TABLET;ORAL076511-001Dec 15, 2006RXNo<disabled><disabled>
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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
PROPECIA
finasteride
TABLET;ORAL020788-001Dec 19, 19974,760,071<disabled>
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19924,377,584<disabled>
Merck
PROSCAR
finasteride
TABLET;ORAL020180-001Jun 19, 19925,886,184<disabled>
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International Patent Family for Ingredient: finasteride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9921563<disabled in preview>
Australia731576<disabled in preview>
Canada2308070<disabled in preview>
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