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Details for Generic Name: drospirenone; ethinyl estradiol

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Drospirenone; ethinyl estradiol is the generic ingredient in nine branded drugs marketed by Barr, Glenmark Pharms Ltd, Watson Labs, Sandoz, Lupin Ltd, Bayer Hlthcare, Jai Pharma Ltd, and Novast Labs Ltd, and is included in fifteen NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and one patent family members in forty-two countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: drospirenone; ethinyl estradiol

Drug Master File Entries: see list10
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details


Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL3MG,N/A; 0.02MG,N/A; 0.451MG,0.451MG

Clinical Trials for: drospirenone; ethinyl estradiol

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Fasting Conditions.
Status: Completed Condition: Healthy

Drospirenone/Ethinyl Estradiol (3 mg/0.02 mg) Tablets Under Non-Fasting Conditions
Status: Completed Condition: Healthy

Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
Status: Completed Condition: Polycystic Ovary Syndrome; Estro-progestin Drugs

Clinical, Metabolic and Endocrine Effects of the Treatment With Drospirenone and Ethinyl Estradiol Alone or in Combination With Myo-inositol in Young Women With Polycystic Ovary Syndrome (PCOS) and Insulin Resistance
Status: Completed Condition: PCOS; Polycystic Ovary Syndrome

Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Status: Active, not recruiting Condition: Polycystic Ovary Syndrome

Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
Status: Completed Condition: Contraception

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo5,798,338<disabled>Y <disabled>
Bayer Hlthcare
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001RXYes6,933,395<disabled>Y <disabled>
Bayer Hlthcare
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RXYes6,958,326<disabled>Y <disabled>
Watson Labs
drospirenone; ethinyl estradiol
TABLET;ORAL-28090081-001Sep 7, 2010RXNo<disabled><disabled>
drospirenone; ethinyl estradiol
TABLET;ORAL-28090114-001Mar 28, 2011RXNo<disabled><disabled>
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International Patent Family for Ingredient: drospirenone; ethinyl estradiol

Country Document Number Publication Date
Czech Republic300514Jun 03, 2009
Russian Federation2269342Oct 27, 2007
South Africa200404083Feb 22, 2006
Slovenia918791Dec 31, 2002
European Patent Office1214076Nov 19, 2003
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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