KOMBIGLYZE XR Drug Patent Profile

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 two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in thirty-two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kombiglyze Xr

A generic version of KOMBIGLYZE XR was approved as metformin hydrochloride; saxagliptin hydrochloride by DR REDDYS LABS SA on August 9^th, 2023.

Summary for KOMBIGLYZE XR

International Patents:	57
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	73
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for KOMBIGLYZE XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KOMBIGLYZE XR
DailyMed Link:	KOMBIGLYZE XR at DailyMed

See drug prices for KOMBIGLYZE XR

Recent Clinical Trials for KOMBIGLYZE XR

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

Sponsor	Phase
The First Affiliated Hospital of Guangzhou Medical University	Phase 3
The University of Hong Kong	Phase 3
Karolinska Institutet	Phase 3

See all KOMBIGLYZE XR clinical trials

Pharmacology for KOMBIGLYZE XR

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for KOMBIGLYZE XR

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for KOMBIGLYZE XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KOMBIGLYZE XR	Extended-release Tablets	metformin hydrochloride; saxagliptin hydrochloride	5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg	200678	3	2013-07-31

US Patents and Regulatory Information for KOMBIGLYZE XR

KOMBIGLYZE XR is protected by two US patents.

Patents protecting 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		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010		DISCN	Yes	No			Y
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010		DISCN	Yes	No			Y

Expired US Patents for KOMBIGLYZE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-003	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-001	Nov 5, 2010
Astrazeneca Ab	KOMBIGLYZE XR	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200678-002	Nov 5, 2010

International Patents for KOMBIGLYZE XR

When does loss-of-exclusivity occur for KOMBIGLYZE XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KOMBIGLYZE XR around the world.

Country	Patent Number	Title	Estimated Expiration
China	1427826
Spain	2456667
Ukraine	88168	ПРЕПАРАТ В ВИДЕ ТАБЛЕТКИ САКСАГЛИПТИНА С ПОКРЫТИЕМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ;ПРЕПАРАТ У ВИГЛЯДІ ТАБЛЕТКИ САКСАГЛІПТИНУ З ПОКРИТТЯМ І СПОСІБ ЙОГО ВИГОТОВЛЕННЯ (COATED TABLET FORMULATION COMPRISING SAXAGLIPITIN AND METHOD FOR FORMING THEREOF)
Poland	1753406
Hungary	S1200030

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2498758	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
2498758	2020C/509	Belgium		PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113