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Details for Patent: 7,135,465

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Patent 7,135,465 protects ZERIT XR and is included in one NDA. There are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

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

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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 45th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Bristol Myers Squibb
CAPSULE, EXTENDED RELEASE;ORAL021453-001Dec 31, 2002DISCNNo7,135,465*PEDAug 18, 2023Y
Bristol Myers Squibb
CAPSULE, EXTENDED RELEASE;ORAL021453-002Dec 31, 2002DISCNNo7,135,465*PEDAug 18, 2023Y
Bristol Myers Squibb
CAPSULE, EXTENDED RELEASE;ORAL021453-003Dec 31, 2002DISCNNo7,135,465*PEDAug 18, 2023Y
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.