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Last Updated: December 3, 2024

Danazol - Generic Drug Details


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

Danazol is the generic ingredient in two branded drugs marketed by Am Therap, Barr, Lannett Co Inc, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for danazol. Four suppliers are listed for this compound.

Summary for danazol
Drug Prices for danazol

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Recent Clinical Trials for danazol

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

SponsorPhase
Chinese PLA General HospitalPhase 2
Peking University Third HospitalPhase 2
Beijing Tsinghua Changgeng HospitalPhase 2

See all danazol clinical trials

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
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc DANAZOL danazol CAPSULE;ORAL 077246-003 Apr 19, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Barr DANAZOL danazol CAPSULE;ORAL 074582-003 May 29, 1998 AB RX No 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

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