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-two branded drugs marketed by Schering, Pharmacia And Upjohn, Organon Usa Inc, Gd Searle Llc, Watson Pharms Teva, Watson Labs, Mylan Labs Ltd, Barr, Novast Labs, Dr Reddys Labs Sa, Amneal, Xiromed, Teva Pharms Usa Inc, Organon Usa Organon, Pfizer, Parke Davis, Agile, Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Amneal Pharms, Glenmark Pharms Ltd, 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, Vintage Pharms Llc, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, Mylan Technologies, Apil, Allergan, Ortho Mcneil Pharm, LPI, Watson Labs Teva, Ortho Mcneil Janssen, Warner Chilcott, Vintage Pharms, Warner Chilcott Llc, Slayback Pharma Llc, Lupin, Barr Labs Inc, Apotex, Glenmark Pharms, Mylan, Lupin Pharms, and Mayne Pharma, and is included in three hundred and one 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: | 232 |
Applicants: | 57 |
NDAs: | 301 |
Drug Master File Entries: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 222 |
Patent Applications: | 6,692 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Parexel | Phase 1 |
Lupin Research Inc | Phase 2 |
Women's Hospital School Of Medicine Zhejiang University | Phase 4 |
Generic filers with tentative approvals for ETHINYL ESTRADIOL
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 0.03MG,0.01MG; 0.15MG,N/A | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 0.01MG,0.01MG;1MG,N/A | TABLET;ORAL |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering | ESTINYL | ethinyl estradiol | TABLET;ORAL | 005292-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Usa Inc | LYNORAL | ethinyl estradiol | TABLET;ORAL | 005490-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Labs Ltd | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 206053-001 | Oct 2, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma | NYLIA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207056-001 | Oct 21, 2016 | 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 |