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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. Twenty-seven suppliers are listed for this compound. Additional details are available on the finasteride profile page.
DrugPatentWatch® 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.
Summary for PROSCAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 13 |
| Patent Applications: | 4,101 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROSCAR |
| What excipients (inactive ingredients) are in PROSCAR? | PROSCAR excipients list |
| DailyMed Link: | PROSCAR at DailyMed |
Recent Clinical Trials for PROSCAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Urologic Consultants of Southeastern PA | Phase 4 |
| Merck Frosst Canada Ltd. | Phase 3 |
| University Health Network, Toronto | Phase 3 |
Pharmacology for PROSCAR
| Drug Class | 5-alpha Reductase Inhibitor |
| Mechanism of Action | 5-alpha Reductase Inhibitors |
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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >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 | Try Before You Buy | Try Before You Buy |
| Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Try Before You Buy | Try Before You Buy |
| Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Try Before You Buy | Try Before You Buy |
| Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Try Before You Buy | Try Before You Buy |
| Merck | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROSCAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 7083591 | Try Before You Buy |
| Taiwan | 257766 | Try Before You Buy |
| Czech Republic | 9501268 | Try Before You Buy |
| Germany | 599376 | Try Before You Buy |
| Ireland | 48127 | Try Before You Buy |
| Australia | 3916785 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROSCAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0155096 | SPC/GB93/006 | United Kingdom | Try Before You Buy | SPC/GB93/006:, EXPIRES: 20070526 |
| 0155096 | 93C0055 | Belgium | Try Before You Buy | PRODUCT NAME: FINASTERIDUM; NAT. REG..: 922 IS 151 F 3 19930125; FIRST REG.: GB PL 0025/0279 19920527 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
