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PROSCAR Drug Profile
» See Plans and Pricing
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.
Summary for PROSCAR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 13 |
| Patent Applications: | 5,599 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROSCAR |
| 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 | 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 |
International Patents for PROSCAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 126826 | Start Trial |
| Austria | 377767 | Start Trial |
| Cyprus | 1807 | Start Trial |
| China | 1058018 | Start Trial |
| Canada | 2103107 | Start Trial |
| Norway | 903656 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
