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Last Updated: June 14, 2021

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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.

There are eight drug master file entries for desogestrel; ethinyl estradiol. 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
Milton S. Hershey Medical CenterPhase 3
National Institutes of Health (NIH)Phase 3

See all desogestrel; ethinyl estradiol clinical trials

Paragraph IV (Patent) Challenges for DESOGESTREL; ETHINYL ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
MIRCETTE TABLET;ORAL-28 desogestrel; ethinyl estradiol 020713

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
Xiromed VOLNEA desogestrel; ethinyl estradiol TABLET;ORAL-28 202689-001 Sep 9, 2016 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Glenmark Generics VIORELE desogestrel; ethinyl estradiol TABLET;ORAL-28 091346-001 Apr 2, 2012 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Duramed Pharms Barr VELIVET desogestrel; ethinyl estradiol TABLET;ORAL-28 076455-001 Feb 24, 2004 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc DESOGEN desogestrel; ethinyl estradiol TABLET;ORAL-21 020071-001 Dec 10, 1992   Get Started Free   Get Started Free
Organon Usa Inc DESOGEN desogestrel; ethinyl estradiol TABLET;ORAL-28 020071-002 Dec 10, 1992   Get Started Free   Get Started Free
Aspen Global Inc CYCLESSA desogestrel; ethinyl estradiol TABLET;ORAL-28 021090-001 Dec 20, 2000   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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