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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, Jai Pharma Ltd, Watson Labs, Sandoz, Lupin Ltd, Bayer Hlthcare, and Novast Labs Ltd, and is included in sixteen 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 two 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

Tradenames:9
Patents:8
Applicants:8
NDAs:16
Drug Master File Entries: see list10
Suppliers / Packaging: see list8

Tentative approvals for DROSPIRENONE; ETHINYL ESTRADIOL

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: Completed 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 ClinicalTrials.org
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
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes7,163,931<disabled> <disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RXYes7,163,931<disabled> <disabled>
Sandoz
LORYNA
drospirenone; ethinyl estradiol
TABLET;ORAL079221-001Mar 28, 2011RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE38253<disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 20065,569,652<disabled>
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 20015,569,652<disabled>
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International Patent Family for Ingredient: drospirenone; ethinyl estradiol

Country Document Number Publication Date
Norway327588May 16, 2011
Portugal1214076Apr 30, 2004
Portugal1149840Mar 31, 2009
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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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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