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Last Updated: November 2, 2024

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
Drug Prices for bicalutamide

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Recent Clinical Trials for bicalutamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1
University of California, San FranciscoPhase 1
Changhai HospitalN/A

See all bicalutamide clinical trials

Pharmacology 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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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.