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Details for Patent: 6,475,521
Which drugs does patent 6,475,521 protect, and when does it expire?
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
Bristol Myers Squibb | GLUCOPHAGE XR | metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021202-004 | Apr 11, 2003 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
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 |
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 | ➤ Try a Free Trial |
Patent No. | Title | Estimated Patent Expiration |
International Patents Family Members for US Patent 6,475,521
Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
African Intellectual Property Organization (OAPI) | 11484 | ➤ Try a Free Trial | |||
New Zealand | 506202 | ➤ Try a Free Trial | |||
Japan | 4523153 | ➤ Try a Free Trial | |||
Japan | 2002506812 | ➤ Try a Free Trial | |||
Country | Document Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |