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Last Updated: November 21, 2024

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
Drug patent expirations by year for ETHINYL ESTRADIOL AND NORELGESTROMIN
Recent Clinical Trials for ETHINYL ESTRADIOL AND NORELGESTROMIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mylan Inc.Phase 3
Mylan Technologies Inc.Phase 3
Janssen Research & Development, LLCPhase 4

See all ETHINYL ESTRADIOL AND NORELGESTROMIN clinical trials

Pharmacology for ETHINYL ESTRADIOL AND NORELGESTROMIN
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen 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

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