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SYNJARDY Drug Profile

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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 seven patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-six patent family members in forty-four 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.

US ANDA Litigation and Generic Entry Outlook for Synjardy

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 1, 2028. This may change due to patent challenges or generic licensing.

There have been four 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:	186
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	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
DailyMed Link:	SYNJARDY at DailyMed

See drug prices for SYNJARDY

Generic Entry Opportunity Date for SYNJARDY

NDA:

206111

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SYNJARDY

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

Paragraph IV (Patent) Challenges for SYNJARDY

Tradename	Dosage	Ingredient	NDA	Submissiondate
SYNJARDY	TABLET;ORAL	empagliflozin; metformin hydrochloride	206111	2018-08-01

US Patents and Regulatory Information for 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	208658-004	Dec 9, 2016		RX	Yes	Yes			Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	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

International Patents for SYNJARDY

Country	Patent Number	Estimated Expiration
Norway	335264
Japan	6431959
Germany	102004040168

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	92555	Luxembourg		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522