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 patent protection?
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.Nine suppliers are listed for this compound.
Summary for ETHINYL ESTRADIOL; NORGESTREL
| US Patents: | 0 |
| Tradenames: | 12 |
| Applicants: | 8 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 9 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORGESTREL
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | NORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 202875-001 | May 8, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | OGESTREL 0.5/50-21 | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075406-001 | Dec 15, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Pharms | OVRAL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 016806-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Dr Reddys Labs Sa | LOW-OGESTREL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 075288-002 | Jul 28, 1999 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Duramed Pharms Barr | CRYSELLE | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 075840-002 | Nov 30, 2001 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cadence Health | LO/OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 017612-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Cadence Health | LO/OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 017612-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 016672-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | OVRAL | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 016672-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | LO/OVRAL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 017802-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Wyeth Pharms | LO/OVRAL-28 | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 017802-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
