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Generated: July 20, 2017
| Title: | Compositions of estrogen-cyclodextrin 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 Aktiengesellchaft (Berlin, DE) |
| Application Number: | 11/102,681 |
|
Patent Claim Types: see list of patent claims | Use; Composition; |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | AB | RX | No | No | 7,163,931 | ► Subscribe | PREVENTION OF PREGNANCY | |||||||||||||||||
Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | 7,163,931 | ► Subscribe | PREVENTION OF PREGNANCY | |||||||||||||||||
Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | AB | RX | Yes | Yes | 7,163,931 | ► Subscribe | PREVENTION OF PREGNANCY | |||||||||||||||||
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| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| 00610135 | Dec 20, 2000 | |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,958,326 | Cyclodextrin-drospirenone inclusion complexes | ► Subscribe | |||||||||||||||||||||||||||
| 7,569,557 | Compositions 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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| Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Serbia | 20090299 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 50362 | ► Subscribe | |||||||||||||||||||||||||||
| Yugoslavia | 51203 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 361799 | ► Subscribe | |||||||||||||||||||||||||||
| Peru | 07092002 | ► 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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Serving 500+ biopharmaceutical companies globally:
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