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Details for Generic Name: drospirenone; ethinyl estradiol; levomefolate calcium

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

This ingredient has one hundred and three patent family members in thirty-nine countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol; levomefolate calcium. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: drospirenone; ethinyl estradiol; levomefolate calcium

Tradenames:2
Patents:5
Applicants:1
NDAs:2
Drug Master File Entries: see list10
Suppliers / Packaging: see list8
Formulation / Manufacturing:see details

Tentative approvals for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

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; levomefolate calcium

Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
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

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

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

INAS-FOCUS (International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study)
Status: Recruiting Condition: Contraception

Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Status: Completed Condition: Polycystic Ovary Syndrome

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, 2010RXYes6,441,168<disabled>Y<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo6,958,326<disabled>Y<disabled>
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes6,958,326<disabled>Y<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo5,798,338<disabled>Y<disabled>
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes5,798,338<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol; levomefolate calcium

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
7,569,557Compositions of estrogen-cyclodextrin complexes<disabled in preview>
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International Patent Family for Ingredient: drospirenone; ethinyl estradiol; levomefolate calcium

Country Document Number Publication Date
China1268396Aug 09, 2006
World Intellectual Property Organization (WIPO)9602277Feb 01, 1996
European Patent Office1632237Apr 12, 2006
China1154648Jun 23, 2004
European Patent Office2192120Oct 26, 2011
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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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