BICALUTAMIDE Drug Patent Profile
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Which patents cover Bicalutamide, and what generic alternatives are available?
Bicalutamide is a drug marketed by Accord Hlthcare, Adaptis, Apotex, Chartwell Rx, Fresenius Kabi Usa, Kudco Ireland, Rising, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, and Watson Labs Teva. and is included in thirteen NDAs.
The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bicalutamide
A generic version of BICALUTAMIDE was approved as bicalutamide by ACCORD HLTHCARE on July 6th, 2009.
Summary for BICALUTAMIDE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 144 |
| Clinical Trials: | 181 |
| Patent Applications: | 6,002 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BICALUTAMIDE |
| What excipients (inactive ingredients) are in BICALUTAMIDE? | BICALUTAMIDE excipients list |
| DailyMed Link: | BICALUTAMIDE at DailyMed |
Recent Clinical Trials for BICALUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Colorado, Denver | Phase 4 |
| Royal College of Surgeons, Ireland | N/A |
| University of Birmingham | N/A |
Pharmacology for BICALUTAMIDE
| Drug Class | Androgen Receptor Inhibitor |
| Mechanism of Action | Androgen Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for BICALUTAMIDE
US Patents and Regulatory Information for BICALUTAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078917-001 | Jul 6, 2009 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rising | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079185-001 | Jul 6, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chartwell Rx | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 091011-001 | Jun 10, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 076932-001 | Jul 6, 2009 | DISCN | No | No | ⤷ 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 |
