Details for Patent: 7,135,465

Which drugs does patent 7,135,465 protect, and when does it expire?

Patent 7,135,465 protects ZERIT XR and is included in one NDA.

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

This patent has twenty-eight patent family members in twenty-five countries.

Summary for Patent: 7,135,465

Title:	Sustained release beadlets containing stavudine
Abstract:	Extended dosage forms of stavudine are provided comprising beadlets formed by extrusion-spheronization and coated with a seal coating. The beadlets are also coated with a modified release coating such that a hard gelatin capsule containing such beadlets will provide blood levels of stavudine over approximately 24 hours. The beadlets are prepared from a dry blend of stavudine, a spheronizing agent, a suitable diluent and a stabilizing amount of magnesium stearate. The magnesium stearate, in contrast to other similar pharmaceutical adjuncts, has been found to stabilize stavudine against degradation due to hydrolysis in the presence of the limited amount of water necessary for the extrusion-spheronization process. Also included in the scope of the invention are hard gelatin capsules containing, in addition to the stavudine beadlets, similar beadlets containing other therapeutic agents utilized to treat retroviral infections.
Inventor(s):	Abramowitz; Robert (West Windsor, NJ), O'Donoghue; Denise M. (Hightstown, NJ), Jain; Nemichand B. (West Windsor, NJ)
Assignee:	Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:	09/821,103
Patent Claim Types: see list of patent claims	Dosage form; Use; Process;

Drugs Protected by US Patent 7,135,465

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No					Y
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No					Y
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002		DISCN	No	No					Y
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002		DISCN	No	No					Y

International Family Members for US Patent 7,135,465

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	027748
Australia	4959101
Bulgaria	107157
Brazil	0109602
Canada	2404687
China	1187052