Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Last Updated: November 12, 2019

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 twenty-four 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.

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

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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

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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
>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
1532149 C300569 Netherlands   Start Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1261586 2012C/016 Belgium   Start Trial PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1532149 92128 Luxembourg   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Harvard Business School
AstraZeneca
McKesson
Johnson and Johnson

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.