TESTOLACTONE - Generic Drug Details
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What are the generic drug sources for testolactone and what is the scope of patent protection?
Testolactone
is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for testolactone.
Summary for TESTOLACTONE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 4 |
Patent Applications: | 6,945 |
Formulation / Manufacturing: | see details |
DailyMed Link: | TESTOLACTONE at DailyMed |
Recent Clinical Trials for TESTOLACTONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Swiss Group for Clinical Cancer Research | Phase 2 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 |
Medical Subject Heading (MeSH) Categories for TESTOLACTONE
US Patents and Regulatory Information for TESTOLACTONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | TESLAC | testolactone | INJECTABLE;INJECTION | 016119-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol Myers Squibb | TESLAC | testolactone | TABLET;ORAL | 016118-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol Myers Squibb | TESLAC | testolactone | TABLET;ORAL | 016118-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |