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Serving leading biopharmaceutical companies globally:

Farmers Insurance
UBS
Mallinckrodt
Healthtrust
Julphar
Fish and Richardson
Novartis
Harvard Business School
Citi
Johnson and Johnson

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for Patent: 6,475,521

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Summary for Patent: 6,475,521
Title: Biphasic controlled release delivery system for high solubility pharmaceuticals and method
Abstract:A biphasic controlled release delivery system for pharmaceuticals which have high water solubility, such as the antidiabetic metformin HCl salt, is provided which provides a dosage form that has prolonged gastric residence so that a dosing regimen of at least one gram metformin, once daily, may be achieved while providing effective control of plasma glucose. The delivery system includes (1) an inner solid particulate phase formed of substantially uniform granules containing a pharmaceutical having a high water solubility, and one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, and (2) an outer solid continuous phase in which the above granules of inner solid particulate phase are embedded and dispersed throughout, the outer solid continuous phase including one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, which may be compressed into tablets or filled into capsules. Methods for forming the so-described biphasic controlled release delivery system and using such biphasic controlled release delivery system for treating diabetes are also provided.
Inventor(s): Timmins; Peter (Irby, GB), Dennis; Andrew B. (Barnston, GB), Vyas; Kiren A. (Canterbury, GB)
Assignee: Bristol-Myers Squibb Co. (Princeton, NJ)
Application Number:09/398,107
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Process; Delivery;

Drugs Protected by US Patent 6,475,521

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
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 AB1 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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

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Non-Orange Book US Patents Family Members for Patent 6,475,521

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
6,660,300 Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 6,475,521

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 1224 ➤ Subscribe
Australia 3182899 ➤ Subscribe
Australia 736951 ➤ Subscribe
Brazil 9908911 ➤ Subscribe
Canada 2320900 ➤ Subscribe
China 1203846 ➤ Subscribe
China 1295467 ➤ Subscribe
Eurasian Patent Organization 003101 ➤ Subscribe
Eurasian Patent Organization 200000968 ➤ Subscribe
European Patent Office 1063973 ➤ Subscribe
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Julphar
Merck
Dow
Cantor Fitzgerald
US Department of Justice
Deloitte
Federal Trade Commission
McKinsey

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