NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Drug Patent Profile
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Which patents cover Norethindrone Acetate And Ethinyl Estradiol, and what generic alternatives are available?
Norethindrone Acetate And Ethinyl Estradiol is a drug marketed by Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Mylan, Amneal Pharms, Apotex, and Xiromed. and is included in twenty-three NDAs.
The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 23 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 13 |
Patent Applications: | 172 |
Formulation / Manufacturing: | see details |
DailyMed Link: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL at DailyMed |
Recent Clinical Trials for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Virginia | Early Phase 1 |
Ironwood Pharmaceuticals, Inc. | Phase 1 |
University of Pennsylvania | Phase 3 |
See all NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL clinical trials
Pharmacology for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
US Patents and Regulatory Information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Barr Labs Inc | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 076221-001 | Nov 6, 2009 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amneal Pharms | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 207514-001 | Sep 11, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Xiromed | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 209609-001 | Jul 16, 2018 | 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 |