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Details for Patent: RE44186

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Patent RE44186 protects ONGLYZA and KOMBIGLYZE XR and is included in two NDAs. There have been zero Paragraph IV challenges on Onglyza and Kombiglyze XR

This patent has sixty-three patent family members in thirty-two countries.

Summary for Patent: RE44186

Title:Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Abstract: Dipeptidyl peptidase IV (DP 4) inhibiting compounds are provided having the formula ##STR00001## where x is 0 or 1 and y is 0 or 1 (provided that x=1 when y=0 and x=0 when y=1); n is 0 or 1; X is H or CN; and wherein R.sup.1, R.sup.2, R.sup.3 and R.sup.4 are as described herein. A method is also provided for treating diabetes and related diseases, especially Type II diabetes, and other diseases as set out herein, employing such DP 4 inhibitor *or a combination of such DP 4 inhibitor and one or more of another antidiabetic agent such as metformin, glyburide, troglitazone, pioglitazone, rosiglitazone and/or insulin and/or one or more of a hypolipidemic agent and/or anti-obesity agent and/or other therapeutic agent.
Inventor(s): Robl; Jeffrey A. (Newtown, PA), Sulsky; Richard B. (Pennington, NJ), Augeri; David J. (Princeton, NJ), Magnin; David R. (Sumter, SC), Hamann; Lawrence G. (Cambridge, MA), Betebenner; David A. (Lawrenceville, NJ)
Assignee: Bristol-Myers Squibb Company (Princeton, NJ)
Application Number:13/308,658
Patent Claim Types:
see list of patent claims
Compound; Composition; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXNoRE44186► subscribeYY METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXNoRE44186► subscribeYY METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesRE44186► subscribeYY METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA
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Non-Orange Book Patents for Patent: RE44186

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
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: RE44186

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina027634► subscribe
Austria396176► subscribe
Australia2001245466► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.

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