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Details for Patent: 7,163,931

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Which drugs does patent 7,163,931 protect, and when does it expire?

Patent 7,163,931 protects BEYAZ, SAFYRAL, and YAZ, and is included in three NDAs.

This patent has sixty patent family members in thirty-seven countries.

Summary for Patent: 7,163,931

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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,163,931
Patent Claim Types: see list of patent claims	Use; Composition;

Drugs Protected by US Patent 7,163,931

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	No	No						PREVENTION OF PREGNANCY
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	AB	RX	Yes	Yes						PREVENTION OF PREGNANCY
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	AB	RX	Yes	Yes						PREVENTION OF PREGNANCY

Foreign Priority and PCT Information for Patent: 7,163,931

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

Non-Orange Book US Patents Family Members for Patent 7,163,931

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
7,569,557	Compositions of estrogen-cyclodextrin complexes

International Family Members for US Patent 7,163,931

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	032205
Austria	311204
Australia	1941802
Australia	2002219418