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Details for Patent: 6,475,521

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Which drugs does patent 6,475,521 protect, and when does it expire?

Patent 6,475,521 protects GLUCOPHAGE XR and is included in one NDA.

This patent has seventeen patent family members in twelve countries.

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
Bristol Myers Squibb	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	AB	RX	Yes	Yes

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

International 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
Australia	3182899
Australia	736951
Brazil	9908911