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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Fuji
Citi
US Army
Daiichi Sankyo
McKesson
Farmers Insurance
Express Scripts
Mallinckrodt

Generated: June 24, 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.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 RX Yes No ➤ 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. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31

Non-Orange Book US Patents for KOMBIGLYZE XR

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
7,951,400 Coated tablet formulation and method ➤ Try a Free Trial
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for KOMBIGLYZE XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00357 Netherlands ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
128 Luxembourg ➤ Try a Free Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2012 00014 Denmark ➤ Try a Free Trial
9 5017-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Teva
US Army
Johnson and Johnson
Mallinckrodt
Moodys
Julphar
McKesson
Covington

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