Pharsight

Kombiglyze Xr is owned by Astrazeneca Ab.

Kombiglyze Xr contains Metformin Hydrochloride; Saxagliptin Hydrochloride.

Kombiglyze Xr has a total of 3 drug patents out of which 0 drug patents have expired.

Kombiglyze Xr was authorised for market use on 05 November, 2010.

Kombiglyze Xr is available in tablet, extended release;oral dosage forms.

Kombiglyze Xr can be used as method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin; adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

The generics of Kombiglyze Xr are possible to be released after 13 July, 2025.

Application	Filing Date	Opposition Party	Legal Status
EP10179007A	2017-03-22	Galenicum Health S.L.	Patent maintained as amended
EP05756474A	2017-01-20	Galenicum Health S.L.	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
USRE44186	June, 2016	FWD Entered	ASTRAZENECA AB	Aurobindo Pharma U.S.A., Inc.
USRE44186	June, 2016	FWD Entered	AstraZeneca AB	Amneal Pharmaceuticals LLC
USRE44186	June, 2016	FWD Entered	AstraZeneca AB	Teva Pharmaceuticals USA Inc.
USRE44186	May, 2016	FWD Entered	AstraZeneca AB	Wockhardt Bio AG
USRE44186	June, 2015	FWD Entered	AstraZeneca AB	Mylan Pharmaceuticals Inc.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
USRE44186	ASTRAZENECA AB	Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method	Jul, 2023 (4 months from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9339472	ASTRAZENECA AB	Coated tablet formulation and method	Jul, 2025 (2 years from now)
US8628799	ASTRAZENECA AB	Coated tablet formulation and method	Jul, 2025 (2 years from now)

Drugs and Companies using METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ingredient

Market Authorisation Date: 05 November, 2010

Treatment: Method for treating type ii diabetes mellitus by administering saxagliptin in combination with metformin; Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellit...

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg	31 Jul, 2013	3		31 Jul, 2023

Strength	Dosage	Availability
1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription