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Last Updated: August 6, 2020

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PROSCAR Drug Profile

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When do Proscar patents expire, and what generic alternatives are available?

Proscar is a drug marketed by Merck and is included in one NDA.

The generic ingredient in PROSCAR is finasteride. There are fourteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the finasteride profile page.

US ANDA Litigation and Generic Entry Outlook for Proscar

A generic version of PROSCAR was approved as finasteride by DR REDDYS LABS INC on July 28th, 2006.

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Drug patent expirations by year for PROSCAR
Drug Prices for PROSCAR

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Recent Clinical Trials for PROSCAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Urologic Consultants of Southeastern PAPhase 4
Merck Frosst Canada Ltd.Phase 3
University Health Network, TorontoPhase 3

See all PROSCAR clinical trials

Pharmacology for PROSCAR
Paragraph IV (Patent) Challenges for PROSCAR
Tradename Dosage Ingredient NDA Submissiondate
PROSCAR TABLET;ORAL finasteride 020180

US Patents and Regulatory Information for PROSCAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PROSCAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992   Start Trial   Start Trial
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992   Start Trial   Start Trial
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992   Start Trial   Start Trial
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992   Start Trial   Start Trial
Merck PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PROSCAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0155096 93C0055 Belgium   Start Trial PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527
0155096 SPC/GB93/006 United Kingdom   Start Trial SPC/GB93/006:, EXPIRES: 20070526
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow
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