PROPECIA Drug Patent Profile
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When do Propecia patents expire, and what generic alternatives are available?
Propecia is a drug marketed by Organon and is included in one NDA.
The generic ingredient in PROPECIA is finasteride. There are fourteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the finasteride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Propecia
A generic version of PROPECIA was approved as finasteride by DR REDDYS LABS INC on July 28th, 2006.
Summary for PROPECIA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 103 |
| Clinical Trials: | 10 |
| Patent Applications: | 2,218 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROPECIA |
| What excipients (inactive ingredients) are in PROPECIA? | PROPECIA excipients list |
| DailyMed Link: | PROPECIA at DailyMed |
Recent Clinical Trials for PROPECIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Follicle Pharma Ltd | Phase 1 |
| Inventage Lab., Inc. | Phase 1/Phase 2 |
| Polichem S.A. | Phase 3 |
Pharmacology for PROPECIA
| Drug Class | 5-alpha Reductase Inhibitor |
| Mechanism of Action | 5-alpha Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PROPECIA
US Patents and Regulatory Information for PROPECIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | 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 PROPECIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Organon | PROPECIA | finasteride | TABLET;ORAL | 020788-001 | Dec 19, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROPECIA
See the table below for patents covering PROPECIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 227861 | USE OF 17 BETA-(N-TERT BUTYLCARBAMOYL)-4AZA-5ALPHA-ANDROST-1-ENE-3-ONE FOR THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF ANDROGENIC ALOPECIA | ⤷ Try a Trial |
| Croatia | P20000295 | PROCESS FOR THE PREPARATION OF A NEW FINASTERIDE | ⤷ Try a Trial |
| Greece | 3029554 | ⤷ Try a Trial | |
| Australia | 5078793 | ⤷ Try a Trial | |
| Singapore | 128794 | ⤷ Try a Trial | |
| Latvia | 5723 | 17Beta-(n-t-butilkarbamoil)-4-aza-5-alfa-androsten-3-ons ar testosterona 5-alfa-reduktazes ipasibam | ⤷ Try a Trial |
| Germany | 599376 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROPECIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0155096 | SPC/GB93/006 | United Kingdom | ⤷ Try a Trial | SPC/GB93/006:, EXPIRES: 20070526 |
| 0155096 | 93C0055 | Belgium | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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