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Details for Patent: 6,958,326

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Patent 6,958,326 protects BEYAZ, SAFYRAL, and YAZ, and is included in three NDAs. There have been zero Paragraph IV challenges on Safyral, Yaz, and Beyaz.

This patent has fifty-seven patent family members in thirty-five countries.

Summary for Patent: 6,958,326

Title: Cyclodextrin-drospirenone inclusion complexes
Abstract:Pharmaceutical compositions comprising low doses of sensitive complexes between an estrogen and a cyclodextrin are provided with improved stability. In specific embodiments the composition comprises a complex between ethinyl estradiol and .beta.-cyclodextrin in a granulate preparation and in yet another embodiment the composition comprises a limited amount of polyvinylpyrrolidone since this excipient was found to degrade ethinyl estradiol. Furthermore, a method for improving the stability of an estrogen in a composition and for manufacturing such a stable composition is provided. Essentially, the granulate preparation are manufactured under careful control of the relative humidity.
Inventor(s): Backensfeld; Thomas (Berlin, DE), Heil; Wolfgang (Berlin, DE), Lipp; Ralph (Berlin, DE)
Assignee: Schering AG (Berlin, DE)
Application Number:10/022,845
Patent Claim Types:
see list of patent claims
Composition; Use; Formulation; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 18th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010RXNo6,958,326► subscribeY
Bayer Hlthcare
SAFYRAL
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022574-001Dec 16, 2010RXYes6,958,326► subscribeY
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RXYes6,958,326► subscribeY
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Foreign Priority and PCT Information for Patent: 6,958,326

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
00610135Dec 20, 2000

Non-Orange Book Patents for Patent: 6,958,326

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► subscribe
7,163,931Compositions of estrogen-cyclodextrin complexes► subscribe
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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 Patent: 6,958,326

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea101275372► subscribe
Japan2009102424► subscribe
Japan5015976► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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