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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for Patent: 7,135,465

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

International Family Members for US Patent 7,135,465

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

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