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Last Updated: March 19, 2024

Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details


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

Drospirenone; ethinyl estradiol; levomefolate calcium is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Lupin Ltd, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Recent Clinical Trials for drospirenone; ethinyl estradiol; levomefolate calcium

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

SponsorPhase
BayerPhase 3

See all drospirenone; ethinyl estradiol; levomefolate calcium clinical trials

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BEYAZ Tablets drospirenone; ethinyl estradiol; levomefolate calcium 3 mg/0.02 mg/ 0.451 mg and 0.451 mg 022532 1 2012-11-13
SAFYRAL Tablets drospirenone; ethinyl estradiol; levomefolate calcium 3 mg/0.03 mg/ 0.451 mg and 0.451 mg 022574 1 2012-09-28

US Patents and Regulatory Information for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203594-001 Oct 11, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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; levomefolate calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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