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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, Watson Labs, Sandoz, Lupin Ltd, Bayer Hlthcare, and Novast Labs Ltd, and is included in thirteen NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: drospirenone; ethinyl estradiol

Tradenames:9
Patents:13
Applicants:6
NDAs:13
Drug Master File Entries: see list10
Suppliers: see list5

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

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676Mar 16, 2006RXYes6,958,326<disabled>Y<disabled>
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574Dec 16, 2010RXYes8,617,597<disabled>Y<disabled>
Novast Labs Ltd
YAELA
drospirenone; ethinyl estradiol
TABLET;ORAL-28202015Nov 19, 2014RXNo<disabled><disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532Sep 24, 2010RXNo6,958,326<disabled>Y<disabled>
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574Dec 16, 2010RXYes5,798,338<disabled>Y<disabled>
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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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