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Last Updated: April 16, 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. Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	181
Patent Applications:	6,291
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for bicalutamide
What excipients (inactive ingredients) are in bicalutamide?	bicalutamide excipients list
DailyMed Link:	bicalutamide at DailyMed

See drug prices for bicalutamide

Recent Clinical Trials for bicalutamide

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

Sponsor	Phase
University of Colorado, Denver	Phase 4
University College Dublin	N/A
University of Liverpool	N/A

See all bicalutamide clinical trials

Pharmacology for bicalutamide

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for bicalutamide

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for bicalutamide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Teva	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078634-001	Aug 28, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Adaptis	BICALUTAMIDE	bicalutamide	TABLET;ORAL	079089-001	Jul 6, 2009	AB	RX	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
Sun Pharm	BICALUTAMIDE	bicalutamide	TABLET;ORAL	079110-001	Jul 6, 2009	AB	RX	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

Expired US Patents for bicalutamide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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