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Last Updated: August 3, 2020

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Ethinyl estradiol; etonogestrel - Generic Drug Details

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

Ethinyl estradiol; etonogestrel is the generic ingredient in two branded drugs marketed by Amneal Pharms Llc and Organon Sub Merck, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; etonogestrel. Four suppliers are listed for this compound.

Summary for ethinyl estradiol; etonogestrel
Recent Clinical Trials for ethinyl estradiol; etonogestrel

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

Laboratorios Andromaco S.A.Phase 1
University of Sao PauloPhase 4
Merck Sharp & Dohme Corp.Phase 3

See all ethinyl estradiol; etonogestrel clinical trials

Pharmacology for ethinyl estradiol; etonogestrel
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; ETONOGESTREL
Tradename Dosage Ingredient NDA Submissiondate
NUVARING RING;VAGINAL ethinyl estradiol; etonogestrel 021187 2013-06-17

US Patents and Regulatory Information for ethinyl estradiol; etonogestrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Sub Merck NUVARING ethinyl estradiol; etonogestrel RING;VAGINAL 021187-001 Oct 3, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc ELURYNG ethinyl estradiol; etonogestrel RING;VAGINAL 210830-001 Dec 11, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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