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Last Updated: March 28, 2024

Drospirenone; ethinyl estradiol - Generic Drug Details


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What are the generic sources for drospirenone; ethinyl estradiol and what is the scope of patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Recent Clinical Trials for drospirenone; ethinyl estradiol

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

SponsorPhase
Women's Hospital School Of Medicine Zhejiang UniversityPhase 4
University of California, San FranciscoPhase 4
American University of Beirut Medical CenterPhase 2/Phase 3

See all drospirenone; ethinyl estradiol clinical trials

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YAZ Tablets drospirenone; ethinyl estradiol 3 mg/0.02 mg 021676 1 2006-09-29
YASMIN Tablets drospirenone; ethinyl estradiol 3 mg/0.03 mg 021098 1 2005-01-07

US Patents and Regulatory Information for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lupin Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 201663-001 Dec 18, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm KEMEYA drospirenone; ethinyl estradiol TABLET;ORAL-28 202138-001 Mar 13, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 202594-001 Oct 22, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131-001 May 4, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205947-001 Jun 13, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 drospirenone; ethinyl estradiol

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