ETHINYL ESTRADIOL AND NORELGESTROMIN Drug Patent Profile
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When do Ethinyl Estradiol And Norelgestromin patents expire, and when can generic versions of Ethinyl Estradiol And Norelgestromin launch?
Ethinyl Estradiol And Norelgestromin is a drug marketed by Amneal and Zydus Noveltech Inc and is included in two NDAs.
The generic ingredient in ETHINYL ESTRADIOL AND NORELGESTROMIN is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ethinyl Estradiol And Norelgestromin
A generic version of ETHINYL ESTRADIOL AND NORELGESTROMIN was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25th, 2021.
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Summary for ETHINYL ESTRADIOL AND NORELGESTROMIN
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 6 |
Clinical Trials: | 20 |
DailyMed Link: | ETHINYL ESTRADIOL AND NORELGESTROMIN at DailyMed |
Recent Clinical Trials for ETHINYL ESTRADIOL AND NORELGESTROMIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mylan Technologies Inc. | Phase 3 |
Mylan Inc. | Phase 3 |
Janssen Research & Development, LLC | Phase 4 |
See all ETHINYL ESTRADIOL AND NORELGESTROMIN clinical trials
Pharmacology for ETHINYL ESTRADIOL AND NORELGESTROMIN
Drug Class | Estrogen Progestin |
Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for ETHINYL ESTRADIOL AND NORELGESTROMIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213950-001 | Feb 25, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Noveltech Inc | ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 214594-001 | Sep 14, 2023 | 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 |
EU/EMA Drug Approvals for ETHINYL ESTRADIOL AND NORELGESTROMIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gedeon Richter Plc. | Evra | norelgestromin, ethinyl estradiol | EMEA/H/C/000410 Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years. |
Authorised | no | no | no | 2002-08-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |