FLUTAMIDE - Generic Drug Details

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What are the generic sources for flutamide and what is the scope of patent protection?

Flutamide is the generic ingredient in two branded drugs marketed by Schering, Actavis Labs Fl Inc, Chartwell Rx, Cipla, Norvium Bioscience, and Waylis Therap, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for flutamide. Two suppliers are listed for this compound.

Summary for FLUTAMIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	72
Patent Applications:	7,340
Drug Prices:	Drug price trends for FLUTAMIDE
What excipients (inactive ingredients) are in FLUTAMIDE?	FLUTAMIDE excipients list
DailyMed Link:	FLUTAMIDE at DailyMed

See drug prices for FLUTAMIDE

Recent Clinical Trials for FLUTAMIDE

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

Sponsor	Phase
University of Colorado, Denver	Phase 4
Kafrelsheikh University	Phase 2
2-Faculty of Science, Kafrelsheikh University, Egypt.	Phase 3

See all FLUTAMIDE clinical trials

Pharmacology for FLUTAMIDE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Medical Subject Heading (MeSH) Categories for FLUTAMIDE

Androgen Antagonists
Antineoplastic Agents, Hormonal

Anatomical Therapeutic Chemical (ATC) Classes for FLUTAMIDE

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

US Patents and Regulatory Information for FLUTAMIDE

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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
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780-001	Sep 19, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Waylis Therap	FLUTAMIDE	flutamide	CAPSULE;ORAL	075298-001	Sep 18, 2001		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	FLUTAMIDE	flutamide	CAPSULE;ORAL	075820-001	Sep 18, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	FLUTAMIDE	flutamide	CAPSULE;ORAL	075818-001	Sep 18, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	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 FLUTAMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	⤷ Sign Up	⤷ Sign Up
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	⤷ Sign Up	⤷ Sign Up
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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