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Last Updated: June 23, 2024

Ethinyl estradiol; norelgestromin - Generic Drug Details


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What are the generic sources for ethinyl estradiol; norelgestromin and what is the scope of freedom to operate?

Ethinyl estradiol; norelgestromin is the generic ingredient in four branded drugs marketed by Amneal, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, and Mylan Technologies, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for ethinyl estradiol; norelgestromin
Recent Clinical Trials for ethinyl estradiol; 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; norelgestromin clinical trials

Pharmacology for ethinyl estradiol; norelgestromin
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORELGESTROMIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORTHO EVRA Transdermal System ethinyl estradiol; norelgestromin 0.15 mg/0.02 mg per 24 hours 021180 1 2007-03-22

US Patents and Regulatory Information for ethinyl estradiol; norelgestromin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ONSURA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 213977-001 Aug 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Technologies XULANE ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 200910-001 Apr 16, 2014 AB RX No Yes ⤷  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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ethinyl estradiol; norelgestromin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ethinyl estradiol; 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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