Pharsight

Qtern is owned by Astrazeneca Ab.

Qtern contains Dapagliflozin; Saxagliptin Hydrochloride.

Qtern has a total of 8 drug patents out of which 0 drug patents have expired.

Qtern was authorised for market use on 27 February, 2017.

Qtern is available in tablet;oral dosage forms.

Qtern can be used as treatment of type 2 diabetes mellitus; method for treating type 2 diabetes mellitus (t2dm) in patients who are already treated with dapagliflozin and saxagliptin; method for treating type 2 diabetes mellitus (t2dm) in patients who have inadequate control with dapagliflozin, treatment of type 2 diabetes mellitus, treatment of type 2 diabetes mellitus; method for treating type 2 diabetes mellitus (t2dm) in patients who have inadequate control with dapagliflozin; method for treating type 2 diabetes mellitus (t2dm) in patients who are already treated with dapagliflozin and saxagliptin.

The generics of Qtern are possible to be released after 16 December, 2029.

Application	Filing Date	Opposition Party	Legal Status
EP08732695A	2020-12-11	Galenicum Health S.L.U.	Granted and Under Opposition
EP08732695A	2020-12-11	Generics [UK] Limited	Granted and Under Opposition
EP08732695A	2020-12-11	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP08732695A	2020-12-11	Gedeon Richter Plc.	Granted and Under Opposition
EP08732695A	2020-12-11	Kraus & Weisert Patentanwälte PartGmbB	Granted and Under Opposition
EP08732695A	2020-12-10	Zentiva, k.s.	Granted and Under Opposition
EP17203302A	2020-08-13	Generics (U.K.) Limited	Granted and Under Opposition
EP15181545A	2018-09-06	Generics (U.K.) Limited	Granted and Under Opposition
EP10179007A	2017-03-22	Galenicum Health S.L.	Patent maintained as amended
EP05756474A	2017-01-20	Galenicum Health S.L.	Patent maintained as amended
EP07784499A	2015-04-30	LEK Pharmaceuticals d.d.	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)
US6515117	ASTRAZENECA AB	C-aryl glucoside SGLT2 inhibitors and method	Oct, 2025 (2 years from now)
US7919598	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Dec, 2029 (6 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8628799	ASTRAZENECA AB	Coated tablet formulation and method	Jul, 2025 (2 years from now)
US8501698	ASTRAZENECA AB	Crystal structures of SGLT2 inhibitors and processes for preparing same	Jun, 2027 (4 years from now)
US8221786	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (5 years from now)
US8716251	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (5 years from now)
US8361972	ASTRAZENECA AB	Pharmaceutical formulations containing an SGLT2 inhibitor	Mar, 2028 (5 years from now)

Exclusivity	Exclusivity Expiration
New Strength (NS)	May 2, 2022
New Indication (I)	May 2, 2022

Drugs and Companies using DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE ingredient

Market Authorisation Date: 27 February, 2017

Treatment: Treatment of type 2 diabetes mellitus; Method for treating type 2 diabetes mellitus (t2dm) in patients who have inadequate control with dapagliflozin; Method for treating type 2 diabetes mellitus (t2dm) in patients who are already treated with dapagliflozin and saxagliptin

Dosage: TABLET;ORAL