Ethinyl estradiol; norethindrone - Generic Drug Details
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What are the generic sources for ethinyl estradiol; norethindrone and what is the scope of freedom to operate?
Ethinyl estradiol; norethindrone
is the generic ingredient in one hundred and seventeen branded drugs marketed by Lupin Ltd, Apil, Mylan Labs Ltd, Aurobindo Pharma, Amneal Pharms, Barr, Naari Pte Ltd, Allergan, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Dr Reddys Labs Sa, Glenmark Generics, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Xiromed, Slayback Pharma Llc, Glenmark Pharms Ltd, Teva Pharms Usa Inc, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Apotex, Glenmark Pharms, Parke Davis, and Mylan, and is included in one hundred and forty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ethinyl estradiol; norethindrone
US Patents: | 1 |
Tradenames: | 117 |
Applicants: | 34 |
NDAs: | 149 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 41 |
Patent Applications: | 359 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ethinyl estradiol; norethindrone |
DailyMed Link: | ethinyl estradiol; norethindrone at DailyMed |
Recent Clinical Trials for ethinyl estradiol; norethindrone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Virginia | Early Phase 1 |
Celerion | Phase 1 |
Achillion, a wholly owned subsidiary of Alexion | Phase 1 |
Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE
Applicant | Application No. | Strength | Dosage Form |
⤷ 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.
Pharmacology for ethinyl estradiol; norethindrone
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for ethinyl estradiol; norethindrone
Expired US Patents for ethinyl estradiol; norethindrone
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