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SYNJARDY Drug Patent Profile

Which patents cover Synjardy, and what generic alternatives are available?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-five patent family members in forty-five countries.

The generic ingredient in SYNJARDY 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

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

There have been thirteen 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

International Patents:	235
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SYNJARDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY
What excipients (inactive ingredients) are in SYNJARDY?	SYNJARDY excipients list
DailyMed Link:	SYNJARDY at DailyMed

See drug prices for SYNJARDY

Recent Clinical Trials for SYNJARDY

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

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

See all SYNJARDY clinical trials

Pharmacology for SYNJARDY

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

Paragraph IV (Patent) Challenges for SYNJARDY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNJARDY	Tablets	empagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg	206111	4	2018-08-01

US Patents and Regulatory Information for SYNJARDY

SYNJARDY is protected by nine US patents and two FDA Regulatory Exclusivities.

Patents protecting SYNJARDY

FDA Regulatory Exclusivity protecting SYNJARDY

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	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
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					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No

International Patents for SYNJARDY

See the table below for patents covering SYNJARDY around the world.

Country	Patent Number	Title	Estimated Expiration
China	102573808	Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Hungary	S1400056
Croatia	P20221368
New Zealand	711661	Therapeutic uses of empagliflozin
Eurasian Patent Organization	200601584	ЗАМЕЩЁННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩИЕ ЭТИ СОЕДИНЕНИЯ ЛЕКАРСТВЕННЫЕ СРЕДСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ
Spain	2337498
Cyprus	1109870

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131	2014/055	Ireland		PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	568	Finland
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	C01730131/03	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131	1490061-7	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526