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Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details

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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 seven 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 list1
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

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
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, 2010RXNo6,958,326<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol; levomefolate calcium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE37564<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE43916<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RE37838<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 Estimated Expiration
Norway20001886<disabled in preview>
Uruguay27088<disabled in preview>
Peru07092002<disabled in preview>
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Supplementary Protection Certificates for Tradename: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France<disabled>PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
C0022France<disabled>PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2006 00038Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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