Bicalutamide - Generic Drug Details
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What are the generic drug sources for bicalutamide and what is the scope of patent protection?
Bicalutamide
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Adaptis, Apotex, Chartwell Rx, Fresenius Kabi Usa, Kudco Ireland, Rising, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, Watson Labs Teva, and Ani Pharms, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-nine drug master file entries for bicalutamide. Eight suppliers are listed for this compound.
Summary for bicalutamide
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 14 |
Drug Master File Entries: | 29 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 144 |
Clinical Trials: | 184 |
Patent Applications: | 6,247 |
Drug Prices: | Drug price trends 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 |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
University of California, San Francisco | Phase 1 |
Changhai Hospital | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078575-001 | Jul 6, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Synthon Pharms | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 077973-001 | Jul 6, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs Teva | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078634-001 | Aug 28, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Roxane | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 078285-001 | Mar 24, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Adaptis | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079089-001 | Jul 6, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Kudco Ireland | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 077995-001 | Jul 6, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 bicalutamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Ani Pharms | CASODEX | bicalutamide | TABLET;ORAL | 020498-001 | Oct 4, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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