JARDIANCE Drug Patent Profile

When do Jardiance patents expire, and what generic alternatives are available?

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

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

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Jardiance

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

Annual sales in 2019 were $3.4bn, indicating a strong incentive for generic entry.

There have been fifteen 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.

There are twelve tentative approvals for the generic drug (empagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for JARDIANCE

International Patents:	234
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	68
Patent Applications:	846
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JARDIANCE
Drug Sales Revenues:	Drug sales revenues for JARDIANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JARDIANCE
What excipients (inactive ingredients) are in JARDIANCE?	JARDIANCE excipients list
DailyMed Link:	JARDIANCE at DailyMed

See drug prices for JARDIANCE

See drug sales revenues for JARDIANCE

Recent Clinical Trials for JARDIANCE

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
American Society of Clinical Psychopharmacology	Phase 2
University Health Network, Toronto	Phase 3

See all JARDIANCE clinical trials

Pharmacology for JARDIANCE

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

Anatomical Therapeutic Chemical (ATC) Classes for JARDIANCE

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 JARDIANCE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JARDIANCE	Tablets	empagliflozin	10 mg and 25 mg	204629	14	2018-08-01

US Patents and Regulatory Information for JARDIANCE

JARDIANCE is protected by seven US patents and five FDA Regulatory Exclusivities.

Patents protecting JARDIANCE

FDA Regulatory Exclusivity protecting JARDIANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No					Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No					Y

EU/EMA Drug Approvals for JARDIANCE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jardiance	empagliflozin	EMEA/H/C/002677 Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2014-05-22

International Patents for JARDIANCE

When does loss-of-exclusivity occur for JARDIANCE?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 JARDIANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	142108	CRYSTALLINE FORM OF 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS
South Korea	20150138859	엠파글리플로진의 치료적 용도 (THERAPEUTIC USES OF EMPAGLIFLOZIN)
Hong Kong	1115133

Supplementary Protection Certificates for JARDIANCE

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
2187879	SPC/GB17/031	United Kingdom		PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK...
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527