Ethinyl estradiol; norgestrel - Generic Drug Details
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What are the generic sources for ethinyl estradiol; norgestrel and what is the scope of freedom to operate?
Ethinyl estradiol; norgestrel
is the generic ingredient in twelve branded drugs marketed by Duramed Pharms Barr, Cadence Health, Dr Reddys Labs Sa, Watson Labs, Wyeth Pharms, Novast Labs Ltd, Mylan Labs Ltd, and Lupin Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.Eight suppliers are listed for this compound.
Summary for ethinyl estradiol; norgestrel
US Patents: | 0 |
Tradenames: | 12 |
Applicants: | 8 |
NDAs: | 11 |
Finished Product Suppliers / Packagers: | 8 |
Clinical Trials: | 5 |
DailyMed Link: | ethinyl estradiol; norgestrel at DailyMed |
Recent Clinical Trials for ethinyl estradiol; norgestrel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amgen | Phase 1 |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 1 |
National Cancer Institute (NCI) | Phase 2 |
US Patents and Regulatory Information for ethinyl estradiol; norgestrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | TURQOZ | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 202980-001 | Jul 31, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Labs Ltd | NORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 202875-001 | May 8, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Dr Reddys Labs Sa | LOW-OGESTREL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 075288-002 | Jul 28, 1999 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Duramed Pharms Barr | CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075840-001 | Nov 30, 2001 | 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 |
Expired US Patents for ethinyl estradiol; norgestrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Wyeth Pharms | OVRAL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 016806-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Cadence Health | LO/OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 017612-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | OVRAL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 016806-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 016672-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |