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Profile for Tradename: YASMIN

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Yasmin is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three patent family members in forty-one countries.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for Tradename: YASMIN

Suppliers / Packagers: see list4

Clinical Trials for: YASMIN

Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate
Status: Completed Condition: Contraception

A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
Status: Terminated Condition: Infection, Human Immunodeficiency Virus

Comparison of Body Weight Change During Contraception With Belara and Yasmin
Status: Enrolling by invitation Condition: Body Weight Changes

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Status: Completed Condition: Contraception

Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers
Status: Completed Condition: Contraception

Yasmin Post Marketing Surveillance
Status: Completed Condition: Contraception

Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne
Status: Completed Condition: Acne Vulgaris

Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)
Status: Completed Condition: Contraception

Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)
Status: Completed Condition: Contraception

YAZ Post-marketing Surveillance in Japan
Status: Active, not recruiting Condition: Dysmenorrhea

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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
TABLET;ORAL-28021098-001May 11, 2001RXYes6,787,531<disabled>Y <disabled>
Bayer Hlthcare
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001RXYes6,933,395<disabled>Y <disabled>
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Paragraph IV activity for: YASMIN

Drugname Dosage Strength RLD Submissiondate
drospirenone and ethinyl estradiolTablets3 mg/0.03 mgYasmin1/7/2005

Non-Orange Book Patents for Tradename: YASMIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,121,465 Process for production drospirenone and intermediate products of the process<disabled in preview>
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International Patent Family for Tradename: YASMIN

Country Document Number Publication Date
Germany122009000006May 07, 2009
Russian Federation2010114825Oct 20, 2011
Norway20083854Apr 26, 2002
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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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