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Details for Patent: 7,022,330

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Which drugs does patent 7,022,330 protect, and when does it expire?

Patent 7,022,330 protects IXEMPRA KIT and is included in one NDA.

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

This patent has one hundred and one patent family members in thirty-five countries.

Summary for Patent: 7,022,330

Title:	Parenteral formulation for epothilone analogs
Abstract:	A process for formulating certain epothilone analogs for parenteral administration is disclosed wherein the analog is dissolved in a mixture of at least 50% by volume tertiary-butanol in water, the mixture is lyophilized, the resulting lyophilized product is packaged in one vial with a sufficient amount of solvent comprising anhydrous ethanol and a suitable nonionic surfactant in a second vial. All steps are carried out with protection from light. In use, the contents of the second or diluent vial are added to the lyophilized product and mixed to constitute the epothilone analog and the resulting solution is diluted with a suitable diluent to produce a solution for intravenous injection containing the epothilone analog in a concentration of from about 0.1 mg/mL to about 0.9 mg/mL. A preferred surfactant is polyethoxylated castor oil and a preferred diluent is Lactated Ringer's Injection.
Inventor(s):	Bandyopadhyay; Rebanta (Portage, MI), Malloy; Timothy M. (Yardley, PA), Panaggio; Andrea (West Windsor, NJ), Raghavan; Krishnaswamy Srinivas (Cranbury, NJ), Varia; Sailesh Amilal (Princeton Junction, NJ)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	10/051,727
Patent Claim Types: see list of patent claims	Use; Compound; Process; Composition; Formulation;

Drugs Protected by US Patent 7,022,330

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
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;IV (INFUSION)	022065-001	Oct 16, 2007		RX	Yes	Yes					Y
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;IV (INFUSION)	022065-002	Oct 16, 2007		RX	Yes	Yes					Y

Non-Orange Book US Patents Family Members for Patent 7,022,330

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
8,632,788	Parenteral formulation for epothilone analogs
RE40387	Pharmaceutical compositions, dosage forms and methods for oral administration of epothilones
6,576,651	Pharmaceutical compositions, dosage forms and methods for oral administration of epothilones
6,670,384	Methods of administering epothilone analogs for the treatment of cancer

International Family Members for US Patent 7,022,330

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	032408
Argentina	032409
Argentina	035078
Argentina	098109