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Last Updated: June 28, 2022

Desogestrel; ethinyl estradiol - Generic Drug Details


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

Desogestrel; ethinyl estradiol is the generic ingredient in seventeen branded drugs marketed by Organon Usa Inc, Duramed Pharms Barr, Janssen Pharms, Lupin Ltd, Aspen Global Inc, Mayne Pharma, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Watson Labs, Vintage Pharms Llc, Xiromed, Aurobindo Pharma Ltd, Barr, Vintage Pharms, Teva Branded Pharm, and Glenmark Generics, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

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

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

SponsorPhase
Laboratorios Andromaco S.A.Phase 1
National Institutes of Health (NIH)Phase 3
University of PennsylvaniaPhase 3

See all desogestrel; ethinyl estradiol clinical trials

US Patents and Regulatory Information for desogestrel; ethinyl estradiol

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-CEPT desogestrel; ethinyl estradiol TABLET;ORAL-28 020301-002 Dec 14, 1992 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd SIMLIYA desogestrel; ethinyl estradiol TABLET;ORAL-28 206853-001 Mar 22, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd KALLIGA desogestrel; ethinyl estradiol TABLET;ORAL-28 207081-001 May 17, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mayne Pharma DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076916-001 Dec 29, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd ENSKYCE desogestrel; ethinyl estradiol TABLET;ORAL-28 201887-001 Mar 7, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 desogestrel; ethinyl estradiol

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
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