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Bicalutamide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bicalutamide?

Bicalutamide is the generic ingredient in two branded drugs marketed by Sun Pharma Global, Stason Pharms, Accord Hlthcare, Teva, Actavis Totowa, Fresenius Kabi Oncol, Synthon Pharms, Apotex Inc, Sandoz, Mylan, Roxane, Zydus Pharms Usa Inc, Kudco Ireland, and Astrazeneca, 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. Twenty-four suppliers are listed for this compound.

Summary for Generic Name: bicalutamide

Tradenames:2
Patents:1
Applicants:14
NDAs:14
Drug Master File Entries: see list29
Suppliers / Packagers: see list24
Bulk Api Vendors: see list76
Clinical Trials: see list50
Patent Applications: see list6,770
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bicalutamide at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
BICALUTAMIDE
bicalutamide
TABLET;ORAL078575-001Jul 6, 2009RXNoNo► Subscribe► Subscribe
Fresenius Kabi Oncol
BICALUTAMIDE
bicalutamide
TABLET;ORAL079045-001May 13, 2010RXNoNo► Subscribe► Subscribe
Apotex Inc
BICALUTAMIDE
bicalutamide
TABLET;ORAL200274-001May 21, 2015RXNoNo► Subscribe► Subscribe
Actavis Totowa
BICALUTAMIDE
bicalutamide
TABLET;ORAL078634-001Aug 28, 2009RXNoNo► Subscribe► Subscribe
Kudco Ireland
BICALUTAMIDE
bicalutamide
TABLET;ORAL077995-001Jul 6, 2009DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bicalutamide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 19954,472,382► Subscribe
Astrazeneca
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 19951,712,251► Subscribe
Astrazeneca
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 19955,712,251► Subscribe
Astrazeneca
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 19954,636,505*PED► Subscribe
Astrazeneca
CASODEX
bicalutamide
TABLET;ORAL020498-001Oct 4, 19955,389,613► Subscribe
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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 verifification 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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