EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for empagliflozin; metformin hydrochloride and what is the scope of patent protection?

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has two hundred and sixty-one patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

International Patents:	261
US Patents:	10
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	69
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Novo Nordisk A/S	Phase 3
SINA Health Education and Welfare Trust	Phase 2/Phase 3
SINA Health Education and Welfare Trust	Phase 4

See all EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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
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 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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Glossary

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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	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-003	Aug 26, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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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	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1188776	吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)	⤷ Sign Up
Hong Kong	1213498		⤷ Sign Up
Japan	4181605		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	2014/055	Ireland	⤷ Sign Up	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	C 2014 039	Romania	⤷ Sign Up	PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522
1730131	568	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.