ESTRADIOL; NORGESTIMATE - Generic Drug Details
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What are the generic drug sources for estradiol; norgestimate and what is the scope of freedom to operate?
Estradiol; norgestimate
is the generic ingredient in two branded drugs marketed by Barr and Teva Womens, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for ESTRADIOL; NORGESTIMATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Clinical Trials: | 29 |
DailyMed Link: | ESTRADIOL; NORGESTIMATE at DailyMed |
Recent Clinical Trials for ESTRADIOL; NORGESTIMATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Benha University | Phase 2/Phase 3 |
Amgen | Phase 1 |
Gilead Sciences | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL; NORGESTIMATE
US Patents and Regulatory Information for ESTRADIOL; NORGESTIMATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Barr | ESTRADIOL AND NORGESTIMATE | estradiol; norgestimate | TABLET;ORAL | 076812-001 | Apr 29, 2005 | 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 |
Expired US Patents for ESTRADIOL; NORGESTIMATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |