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
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 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for danazol |
What excipients (inactive ingredients) are in danazol? | danazol excipients list |
DailyMed Link: | danazol at DailyMed |
Recent Clinical Trials for danazol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chinese PLA General Hospital | Phase 2 |
Peking University Third Hospital | Phase 2 |
Beijing Tsinghua Changgeng Hospital | Phase 2 |
Pharmacology for danazol
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for danazol
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lannett Co Inc | DANAZOL | danazol | CAPSULE;ORAL | 077246-002 | 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 | |||
Sanofi Aventis Us | DANOCRINE | danazol | CAPSULE;ORAL | 017557-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Barr | DANAZOL | danazol | CAPSULE;ORAL | 074582-002 | May 29, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lannett Co Inc | DANAZOL | danazol | CAPSULE;ORAL | 077246-001 | Sep 28, 2005 | 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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