DANAZOL Drug Patent Profile
✉ Email this page to a colleague
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. Four 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.
Summary for DANAZOL
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 53 |
Clinical Trials: | 50 |
Patent Applications: | 4,686 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DANAZOL |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Am Therap | DANAZOL | danazol | CAPSULE;ORAL | 071569-001 | Dec 30, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lannett Co Inc | DANAZOL | danazol | CAPSULE;ORAL | 077246-001 | Sep 28, 2005 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Barr | DANAZOL | danazol | CAPSULE;ORAL | 074582-001 | Aug 9, 1996 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Barr | DANAZOL | danazol | CAPSULE;ORAL | 074582-003 | May 29, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |