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Details for Patent: 6,455,518

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Which drugs does patent 6,455,518 protect, and when does it expire?

Patent 6,455,518 protects ZORTRESS and is included in one NDA.

Protection for ZORTRESS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-two patent family members in fifteen countries.

Summary for Patent: 6,455,518

Title:	Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin
Abstract:	A synergistic combination of an IL-2 transcription inhibitor (e.g., cyclosporin A or FK506) and 40-O-(2-hydroxyethyl)-rapamycin is provided, which is useful in the treatment and prevention of transplant rejection and also certain autoimmune and inflammatory diseases, together with novel pharmaceutical compositions comprising an IL-2 transcription inhibitor in combination with a rapamycin, e.g., 40-O-(2-hydroxyethyl)-rapamycin.
Inventor(s):	Zenke; Gerhard (Rheinfelden, DE), Schuurman; Hendrik (Basel, CH), Haeberlin; Barbara (Riehen, CH), Meinzer; Armin (Buggingen, DE)
Assignee:	Novartis AG (Basel, CH)
Application Number:	09/758,301
Patent Claim Types: see list of patent claims	Compound; Composition; Formulation; Use; Dosage form; Device;

Drugs Protected by US Patent 6,455,518

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
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-001	Apr 20, 2010		RX	Yes	No
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-002	Apr 20, 2010		RX	Yes	No
Novartis	ZORTRESS	everolimus	TABLET;ORAL	021560-003	Apr 20, 2010		RX	Yes	Yes

Foreign Priority and PCT Information for Patent: 6,455,518

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9615942	Jul 30, 1996
United Kingdom	9705684	Mar 19, 1997

Non-Orange Book US Patents Family Members for Patent 6,455,518

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
6,239,124	Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin

International Patents Family Members for US Patent 6,455,518

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	222502
Austria	340586
Australia	4012497
Australia	730781