NILUTAMIDE - Generic Drug Details

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

Nilutamide is the generic ingredient in two branded drugs marketed by Concordia and Ani Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nilutamide. Three suppliers are listed for this compound.

Summary for NILUTAMIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	15
Patent Applications:	7,114
Drug Prices:	Drug price trends for NILUTAMIDE
What excipients (inactive ingredients) are in NILUTAMIDE?	NILUTAMIDE excipients list
DailyMed Link:	NILUTAMIDE at DailyMed

See drug prices for NILUTAMIDE

Recent Clinical Trials for NILUTAMIDE

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

Sponsor	Phase
PPD	Phase 3
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair	Phase 3
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB Chair	Phase 3

See all NILUTAMIDE clinical trials

Pharmacology for NILUTAMIDE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NILUTAMIDE

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

US Patents and Regulatory Information for NILUTAMIDE

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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
Concordia	NILANDRON	nilutamide	TABLET;ORAL	020169-001	Sep 19, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	NILUTAMIDE	nilutamide	TABLET;ORAL	207631-001	Jul 15, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia	NILANDRON	nilutamide	TABLET;ORAL	020169-002	Apr 30, 1999	AB	RX	Yes	Yes	⤷ 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

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