DANAZOL Drug Patent 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. 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.
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Questions you can ask:
- What is the 5 year forecast for DANAZOL?
- What are the global sales for DANAZOL?
- What is Average Wholesale Price for DANAZOL?
Summary for DANAZOL
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 53 |
| Clinical Trials: | 51 |
| Patent Applications: | 4,686 |
| 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 |
|---|---|
| Peking University First Hospital | Phase 2 |
| Beijing Luhe Hospital | Phase 2 |
| Chinese PLA General 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 | ⤷ 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 | |||
| Barr | DANAZOL | danazol | CAPSULE;ORAL | 074582-001 | Aug 9, 1996 | AB | RX | No | Yes | ⤷ 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 |
