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Last Updated: May 11, 2021

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DANAZOL Drug Profile

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When do Danazol patents expire, and when can generic versions of Danazol launch?

Danazol is a drug marketed by Am Therap, Barr, and Lannett Co Inc. and is included in three NDAs.

The generic ingredient in DANAZOL is danazol. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the danazol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Danazol

A generic version of DANAZOL was approved as danazol by BARR on August 9th, 1996.

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Drug patent expirations by year for DANAZOL
Drug Prices for DANAZOL

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Recent Clinical Trials for DANAZOL

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Brigham and Women's HospitalPhase 1/Phase 2
The University of QueenslandPhase 2
Parc de Salut MarPhase 1

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Pharmacology for DANAZOL
Drug ClassAndrogen
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for DANAZOL

US Patents and Regulatory Information for DANAZOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Therap DANAZOL danazol CAPSULE;ORAL 071569-001 Dec 30, 1987 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Lannett Co Inc DANAZOL danazol CAPSULE;ORAL 077246-001 Sep 28, 2005 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Barr DANAZOL danazol CAPSULE;ORAL 074582-001 Aug 9, 1996 AB RX No Yes   Get Started for $10   Get Started for $10   Get Started for $10
Barr DANAZOL danazol CAPSULE;ORAL 074582-003 May 29, 1998 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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:

Boehringer Ingelheim
Harvard Business School

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