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 |
|---|---|
| University of California, San Francisco | Phase 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 | |||
| Kudco Ireland | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 077995-001 | Jul 6, 2009 | 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 | |||
| Fresenius Kabi Usa | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079045-001 | May 13, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 200274-001 | May 21, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 076932-001 | Jul 6, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | BICALUTAMIDE | bicalutamide | TABLET;ORAL | 079110-001 | Jul 6, 2009 | AB | RX | 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 |
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.
ISSN: 2162-2639
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