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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. Two suppliers are 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 list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo5,798,338Jul 10, 2015Y
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes8,617,597Feb 8, 2030Y
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes7,163,931Mar 3, 2022
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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, 2010RE43916<disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 20105,798,338<disabled>
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 20105,798,338<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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: drospirenone; ethinyl estradiol; levomefolate calcium

Country Document Number Estimated Expiration
Czech Republic305671<disabled in preview>
Spain2249387<disabled in preview>
Poland361799<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C/GB04/032United Kingdom<disabled>PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0001France<disabled>PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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