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Last Updated: July 31, 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 patent protection?

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Naari Pte Ltd DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 207067-001 Sep 13, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novast Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 091234-001 Jul 12, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 202296-001 Aug 30, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it 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-28 020071-002 Dec 10, 1992 ⤷  Try it Free ⤷  Try it Free
Organon Usa Inc DESOGEN desogestrel; ethinyl estradiol TABLET;ORAL-21 020071-001 Dec 10, 1992 ⤷  Try it Free ⤷  Try it Free
Aspen Global Inc CYCLESSA desogestrel; ethinyl estradiol TABLET;ORAL-28 021090-001 Dec 20, 2000 ⤷  Try it Free ⤷  Try it Free
Janssen Pharms ORTHO-CEPT desogestrel; ethinyl estradiol TABLET;ORAL-28 020301-002 Dec 14, 1992 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
AstraZeneca
Johnson and Johnson
Mallinckrodt
Medtronic

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