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Last Updated: January 20, 2020

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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 twenty-five patent family members in forty countries.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine 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 ANDA Litigation and Generic Entry Outlook for Kombiglyze Xr

  Start Trial

Kombiglyze Xr was eligible for patent challenges on July 31st, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13th, 2025. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Drug patent expirations by year for KOMBIGLYZE XR
Drug Prices for KOMBIGLYZE XR

See drug prices 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.

Recent Clinical Trials for KOMBIGLYZE XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The University of Hong KongPhase 3
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 3
Karolinska InstitutetPhase 3

See all KOMBIGLYZE XR clinical trials

Recent Litigation for KOMBIGLYZE XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca AB v. Mylan Pharmaceuticals Inc.2014-06-03
AstraZeneca AB v. Mylan Pharmaceuticals Inc.2014-06-02
AstraZeneca AB v. Watson Laboratories Inc.2014-05-23

See all KOMBIGLYZE XR litigation

PTAB Litigation
PetitionerDate
Aurobindo Pharma U.S.A., Inc.2016-06-02
Amneal Pharmaceuticals LLC2016-06-01
Teva Pharmaceuticals USA Inc.2016-06-01

See all KOMBIGLYZE XR litigation

Pharmacology for KOMBIGLYZE XR
Synonyms for KOMBIGLYZE XR
1198772-17-6
DTXSID90152608
Kombiglyze
Komboglyze
Metformin / saxagliptin
Metformin mixture with saxagliptin
Saxagliptin / metformin
Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Tradename Dosage Ingredient NDA Submissiondate
KOMBIGLYZE XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; saxagliptin hydrochloride 200678 2013-07-31

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

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 C01261586/02 Switzerland   Start Trial PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1730131 C01730131/02 Switzerland   Start Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1532149 PA2012022 Lithuania   Start Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1261586 SPC/GB10/001 United Kingdom   Start Trial PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
1261586 CA 2010 00007 Denmark   Start Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1261586 CA 2012 00014 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Baxter
Moodys
Dow
AstraZeneca

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