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Last Updated: March 19, 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 freedom to operate?

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 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
Xiromed LORYNA drospirenone; ethinyl estradiol TABLET;ORAL 079221-001 Mar 28, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd LO-ZUMANDIMINE drospirenone; ethinyl estradiol TABLET;ORAL 209632-001 Feb 27, 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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