DANAZOL - Generic Drug Details

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

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

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	51
Patent Applications:	5,826
Drug Prices:	Drug price trends for DANAZOL
What excipients (inactive ingredients) are in DANAZOL?	DANAZOL excipients list
DailyMed Link:	DANAZOL at DailyMed

See drug prices for DANAZOL

Recent Clinical Trials for DANAZOL

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

Sponsor	Phase
Peking University Third Hospital	Phase 2
Beijing Tsinghua Changgeng Hospital	Phase 2
Peking University First Hospital	Phase 2

See all DANAZOL clinical trials

Pharmacology for DANAZOL

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for DANAZOL

Estrogen Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DANAZOL

G03XA	Antigonadotropins and similar agents
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for DANAZOL

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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
Barr	DANAZOL	danazol	CAPSULE;ORAL	074582-001	Aug 9, 1996	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	DANOCRINE	danazol	CAPSULE;ORAL	017557-004	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
>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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