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Empagliflozin - Generic Drug Details

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What are the generic sources for empagliflozin and what is the scope of freedom to operate?

Empagliflozin is the generic ingredient in five branded drugs marketed by Boehringer Ingelheim and is included in five NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has two hundred and twenty-one patent family members in forty-four countries.

There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for empagliflozin

International Patents:	221
US Patents:	19
Tradenames:	5
Applicants:	1
NDAs:	5
Drug Master File Entries:	22
Suppliers / Packagers:	4
Bulk Api Vendors:	73
Clinical Trials:	199
Patent Applications:	758
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin
DailyMed Link:	empagliflozin at DailyMed

Recent Clinical Trials for empagliflozin

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

Sponsor	Phase
EMS	Phase 3
Fondazione Schena	Phase 4
University of Bari	Phase 4

See all empagliflozin clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		25MG/5MG	TABLET;ORAL
		10MG/5MG	TABLET; ORAL
		UNKNOWN	UNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for empagliflozin

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

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
JARDIANCE	TABLET;ORAL	empagliflozin	204629	2018-08-01

US Patents and Regulatory Information for empagliflozin

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 XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	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
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No

International Patents for empagliflozin

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005092877
Portugal	1730131
Argentina	053720
Israel	241102

Supplementary Protection Certificates for empagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	20/2017	Austria		PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	568	Finland
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522