SYNJARDY XR Drug Patent Profile

Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?

Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-six patent family members in forty countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Synjardy Xr

Synjardy Xr was eligible for patent challenges on August 1, 2018.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SYNJARDY XR

International Patents:	166
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SYNJARDY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY XR
DailyMed Link:	SYNJARDY XR at DailyMed

See drug prices for SYNJARDY XR

Recent Clinical Trials for SYNJARDY XR

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

Sponsor	Phase
Genuine Research Center, Egypt	Phase 1
Hikma Pharma	Phase 1

See all SYNJARDY XR clinical trials

Pharmacology for SYNJARDY XR

Drug Class	Biguanide Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SYNJARDY XR

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

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SYNJARDY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNJARDY XR	Extended-release Tablets	empagliflozin; metformin hydrochloride	5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg	208658	3	2018-08-01

US Patents and Regulatory Information for SYNJARDY XR

SYNJARDY XR is protected by seven US patents.

Patents protecting SYNJARDY XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes			Y

Expired US Patents for SYNJARDY XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016

International Patents for SYNJARDY XR

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

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

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Luxembourg

Malaysia

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 SYNJARDY XR around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	011158	ЗАМЕЩЁННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩИЕ ЭТИ СОЕДИНЕНИЯ ЛЕКАРСТВЕННЫЕ СРЕДСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
Slovenia	1730131
Uruguay	29505	FORMA CRISTALINA DE 1-CLORO-4-(B(BETA)-D-GLUCOPIRANOS-1-IL)-2-(4-((S)-TETRAHIDROFURAN-3-ILOXI)-BENCIL)-BENCENO, UN MÉTODO PARA SU PREPARACIÓN Y EL USO DEL MISMO PARA PREPARAR MEDICAMENTOS.

Supplementary Protection Certificates for SYNJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	568	Finland
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522