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Last Updated: July 4, 2020

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Nilutamide - Generic Drug Details

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What are the generic sources for nilutamide and what is the scope of freedom to operate?

Nilutamide is the generic ingredient in two branded drugs marketed by Concordia and Ani Pharms Inc, 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.

Drug Prices for nilutamide

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Recent Clinical Trials for nilutamide

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

SponsorPhase
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3
PPDPhase 2/Phase 3
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all nilutamide clinical trials

Pharmacology for nilutamide

US Patents and Regulatory Information for nilutamide

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 020169-002 Apr 30, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Concordia NILANDRON nilutamide TABLET;ORAL 020169-001 Sep 19, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NILUTAMIDE nilutamide TABLET;ORAL 207631-001 Jul 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Merck
Boehringer Ingelheim
AstraZeneca
Medtronic

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