Pharsight

1. List of Synjardy drug patents

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.
US7713938	BOEHRINGER INGELHEIM	Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments	Apr, 2027 (4 years from now)
US7579449	BOEHRINGER INGELHEIM	Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture	Aug, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610489	BOEHRINGER INGELHEIM	Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof	Sep, 2030 (7 years from now)
US11090323	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (11 years from now)
US10258637	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (11 years from now)

Market Authorisation Date: 26 August, 2015

Treatment: Method of treating type 2 diabetes mellitus in a patent with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin and metformin hcl if egfr>=45 ml/min/1.73 m2 and discontinuation if egfr<30 ml/min/1.73 m2; Method of treating type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=egfr<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg	01 Aug, 2018	4	07 Jul, 2022	03 Apr, 2034	Eligible

Strength	Dosage	Availability
5MG;1GM	TABLET;ORAL	Prescription
5MG;500MG	TABLET;ORAL	Prescription
12.5MG;1GM	TABLET;ORAL	Prescription
12.5MG;500MG	TABLET;ORAL	Prescription

SYNJARDY family patents

European Union

United States

China

Japan

Argentina

Canada

Hong Kong

Korea, Republic of

Peru

Spain

Germany

Israel

Australia

Poland

Uruguay

Cyprus

Mexico

Slovenia

Portugal

Croatia

Norway

New Zealand

Taiwan, Province of China

Denmark

Austria

Brazil

Chile

Ukraine

Hungary

Lithuania

Malaysia

South Africa

Ecuador

Morocco

Luxembourg

Tunisia

Singapore

Turkey

Philippines

India

2. List of Synjardy Xr drug patents

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.
US7713938	BOEHRINGER INGELHEIM	Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments	Apr, 2027 (4 years from now)
US7579449	BOEHRINGER INGELHEIM	Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture	Aug, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10596120	BOEHRINGER INGELHEIM	Pharmaceutical compositions	Mar, 2032 (9 years from now)
US11090323	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (11 years from now)
US10258637	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Apr, 2034 (11 years from now)
US9949998	BOEHRINGER INGELHEIM	Pharmaceutical composition, methods for treating and uses thereof	Jun, 2034 (11 years from now)

Market Authorisation Date: 09 December, 2016

Treatment: Treatment of a type 2 diabetes mellitus patient with insufficient glycemic control despite metformin therapy using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin; Treatment of a treatment-naïve patient with inadequately controlled type 2 diabetes using a composition comprising an extended release core comprising metformin and an outer coating comprising empagliflozin; Method of treating type 2 diabetes mellitus in a patent with renal impairment (egfr<60 ml/min/1.73 m2) by initiation of empagliflozin and metformin hcl if egfr>=45 ml/min/1.73 m2 and discontinuation if egfr<30 ml/min/1.73 m2; Method of treating type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=egfr<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg	01 Aug, 2018	3		11 Jun, 2034

Strength	Dosage	Availability
5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
10MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
12.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription
25MG;1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription

SYNJARDY XR family patents