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Drospirenone; ethinyl estradiol - Generic Drug Details

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Drospirenone; ethinyl estradiol is the generic ingredient in ten branded drugs marketed by Sandoz, Barr, Novast Labs Ltd, Jai Pharma Ltd, Watson Labs, Glenmark Pharms Ltd, Lupin Ltd, and Bayer Hlthcare, and is included in eighteen 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 four patent family members in forty-two countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: drospirenone; ethinyl estradiol

Tradenames:10
Patents:8
Applicants:8
NDAs:18
Drug Master File Entries: see list10
Suppliers / Packaging: see list11
Formulation / Manufacturing:see details

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

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, 2010RXYes8,617,597<disabled>Y <disabled>
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo5,798,338<disabled>Y <disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RXYes6,787,531<disabled>Y <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
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 20015,569,652<disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 20065,569,652<disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE37838<disabled>
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Non-Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

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>
6,121,465 Process for production drospirenone and intermediate products of the process<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

Country Document Number Estimated Expiration
Slovenia1149840<disabled in preview>
Poland354406<disabled in preview>
Cyprus1109252<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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006009Lithuania<disabled>PRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
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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