Ethinyl estradiol - Generic Drug Details
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What are the generic sources for ethinyl estradiol and what is the scope of patent protection?
Ethinyl estradiol
is the generic ingredient in two hundred and thirty-three branded drugs marketed by Schering, Pharmacia And Upjohn, Organon Usa Inc, Gd Searle Llc, Watson Pharms Teva, Watson Labs, Xiromed, Barr, Novast Labs, Dr Reddys Labs Sa, Amneal, Teva Pharms Usa Inc, Organon Usa Organon, Pfizer, Parke Davis, Agile, Glenmark Pharms Ltd, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Amneal Pharms, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Hetero Labs, Naari Pte Ltd, Endo Operations, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, Mylan Technologies, Apil, Allergan, Ortho Mcneil Pharm, LPI, Watson Labs Teva, Ortho Mcneil Janssen, Warner Chilcott, Mylan Labs Ltd, Warner Chilcott Llc, Wilshire Pharms Inc, Millicent Pr, Lupin, Barr Labs Inc, Apotex, Glenmark Speclt, Lupin Pharms, Mylan, and Mayne Pharma, and is included in three hundred and two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for ethinyl estradiol. There are three tentative approvals for this compound.
Summary for ethinyl estradiol
| US Patents: | 17 |
| Tradenames: | 233 |
| Applicants: | 56 |
| NDAs: | 302 |
| Drug Master File Entries: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 227 |
| Patent Applications: | 6,692 |
| Drug Prices: | Drug price trends for ethinyl estradiol |
| DailyMed Link: | ethinyl estradiol at DailyMed |
Recent Clinical Trials for ethinyl estradiol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| Alexion Pharmaceuticals, Inc. | Phase 1 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A |
Generic filers with tentative approvals for ETHINYL ESTRADIOL
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for ethinyl estradiol
Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol
US Patents and Regulatory Information for ethinyl estradiol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 203865-001 | Oct 27, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Duramed Pharms Barr | AVIANE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075796-001 | Apr 30, 2001 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Naari Pte Ltd | NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 200384-001 | Apr 7, 2015 | AB | RX | 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 |
