PROSCAR Drug Patent Profile
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When do Proscar patents expire, and what generic alternatives are available?
Proscar is a drug marketed by Organon 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 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 22 |
Patent Applications: | 453 |
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 |
---|---|
Baylor College of Medicine | Phase 3 |
Medical Research Collaborating Center, Seoul, Korea | Phase 4 |
Astellas Pharma Korea, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for PROSCAR
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 |
---|---|---|---|---|---|---|---|
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | See Plans and Pricing | See Plans and Pricing |
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | See Plans and Pricing | See Plans and Pricing |
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | See Plans and Pricing | See Plans and Pricing |
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | See Plans and Pricing | See Plans and Pricing |
Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROSCAR
See the table below for patents covering PROSCAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 9501268 | See Plans and Pricing | |
Hungary | 210535 | See Plans and Pricing | |
Denmark | 92192 | See Plans and Pricing | |
Israel | 107574 | Process for producing finasteride | See Plans and Pricing |
Czech Republic | 9301933 | See Plans and Pricing | |
Greece | 940300045 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROSCAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0155096 | SPC/GB93/006 | United Kingdom | See Plans and Pricing | SPC/GB93/006:, EXPIRES: 20070526 |
0155096 | 93C0055 | Belgium | See Plans and Pricing | 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 |