BICALUTAMIDE - Generic Drug Details

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

See drug prices for BICALUTAMIDE

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Synthon Pharms	BICALUTAMIDE	bicalutamide	TABLET;ORAL	077973-001	Jul 6, 2009		DISCN	No	No
Chartwell Rx	BICALUTAMIDE	bicalutamide	TABLET;ORAL	091011-001	Jun 10, 2015	AB	RX	No	No
Watson Labs Teva	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078634-001	Aug 28, 2009	AB	RX	No	No
Sandoz	BICALUTAMIDE	bicalutamide	TABLET;ORAL	078575-001	Jul 6, 2009	AB	RX	No	No
Kudco Ireland	BICALUTAMIDE	bicalutamide	TABLET;ORAL	077995-001	Jul 6, 2009		DISCN	No	No
Adaptis	BICALUTAMIDE	bicalutamide	TABLET;ORAL	079089-001	Jul 6, 2009	AB	RX	No	No
Teva	BICALUTAMIDE	bicalutamide	TABLET;ORAL	076932-001	Jul 6, 2009		DISCN	No	No

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
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995
Ani Pharms	CASODEX	bicalutamide	TABLET;ORAL	020498-001	Oct 4, 1995