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. Thirty-four 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: | 102 |
| Clinical Trials: | 22 |
| Patent Applications: | 2,218 |
| 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 |
| Seoul National University Hospital | Phase 4 |
| Medical Research Collaborating Center, Seoul, Korea | Phase 4 |
Pharmacology for PROSCAR
| Drug Class | 5-alpha Reductase Inhibitor |
| Mechanism of Action | 5-alpha Reductase Inhibitors |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
|---|---|---|---|---|---|---|---|
| Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROSCAR | finasteride | TABLET;ORAL | 020180-001 | Jun 19, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Japan | H06199889 | PRODUCTION OF NEW FINASTERIDE | ⤷ Try a Trial |
| Ireland | 850476 | ⤷ Try a Trial | |
| European Patent Office | 0155096 | 17 BETA-SUBSTITUTED-4-AZA-5-ALPHA-ANDROSTENONES AND THEIR USE AS 5-ALPHA-REDUCTASE INHIBITORS | ⤷ Try a Trial |
| Romania | 115165 | PROCEDEU PENTRU PREPARAREA FINASTERIDEI (PROCESS FOR PRODUCING FINASTERIDE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROSCAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0155096 | 93C0055 | Belgium | ⤷ Try a 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 | ⤷ Try a Trial | SPC/GB93/006:, EXPIRES: 20070526 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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