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Generated: December 10, 2018

DrugPatentWatch Database Preview

KOMBIGLYZE XR Drug Profile

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Which patents cover Kombiglyze Xr, and what generic alternatives are available?

Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nineteen patent family members in thirty-nine countries.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Drug patent expirations by year for KOMBIGLYZE XR
Generic Entry Opportunity Date for KOMBIGLYZE XR
Generic Entry Date for KOMBIGLYZE XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KOMBIGLYZE XR

US Patents and Regulatory Information for KOMBIGLYZE XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for KOMBIGLYZE XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2010 00007 Denmark ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
77; 5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
90013-0 Sweden ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Chubb
Chinese Patent Office
Deloitte
Merck
US Army
Colorcon
QuintilesIMS

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