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 fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-eight patent family members in forty-six 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 2022 were $13.0bn, indicating a strong incentive for generic entry.

There have been forty-six 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 seventeen 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:	378
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	82
Patent Applications:	2,158
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
Boehringer Ingelheim	PHASE1
Odense University Hospital	PHASE4
Anita Saraf	PHASE4

See all JARDIANCE clinical trials

Pharmacology for JARDIANCE

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

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 fourteen US patents and five FDA Regulatory Exclusivities.

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	204629-002	Aug 1, 2014		RX	Yes	Yes
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes	11,833,166*PED				Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes	12,115,179*PED				Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	12,263,153
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes	9,949,997*PED				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/002677Type 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
Australia	2019202568	Therapeutic uses of empagliflozin
South Korea	102309654
Lithuania	PA2017014
South Korea	20180122004
China	118286238
Chile	2015003022
Norway	20073875

Supplementary Protection Certificates for JARDIANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	1490061-7	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
2187879	17C1016	France		PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2187879	C20170016 00337	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN/LINAGLIPTIIN;REG NO/DATE: EU/1/16/1146 15.11.2016
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131	C 2014 039	Romania		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	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879	2017/018	Ireland		PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111

Market Dynamics and Financial Trajectory for JARDIANCE

Last updated: November 7, 2025

Introduction

JARDIANCE (empagliflozin) is a pioneering prescription medication developed by Boehringer Ingelheim in collaboration with Eli Lilly. Approved by the FDA in 2014 for the management of type 2 diabetes mellitus (T2DM), JARDIANCE has since emerged as a flagship SGLT2 (sodium-glucose co-transporter 2) inhibitor, integrating both metabolic control and Cardiovascular (CV) risk reduction. As the global diabetes market continues to expand, understanding JARDIANCE’s market dynamics and financial trajectory is critical for stakeholders across healthcare, biotech, and investment sectors.

Market Overview and Drivers

Global Diabetes Prevalence and Market Expansion

The global diabetes epidemic fuels demand for innovative therapeutic options. According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide suffered from diabetes in 2021, with projections exceeding 700 million by 2045 [1]. The Asia-Pacific region, the largest market for T2DM treatments, accounts for nearly 50% of global cases, underscoring regional growth opportunities.

Therapeutic Positioning of JARDIANCE

JARDIANCE stands out due to its dual benefits—glycemic control and CV risk reduction. The landmark EMPA-REG OUTCOME trial demonstrated a significant reduction in major adverse cardiovascular events (MACE), including cardiovascular death, heart failure hospitalization, and all-cause mortality, positioning the drug as a preferred option for high-risk T2DM patients [2]. The inclusion of JARDIANCE in clinical guidelines as a first-line agent for patients with established CV disease fosters robust market demand [3].

Regulatory and Clinical Endorsements

Regulatory authorities globally have issued positive labels. Beyond the U.S., approvals extend to Europe, Japan, and China, with specific indications emphasizing CV and renal benefits. The recent approval of JARDIANCE for heart failure with reduced ejection fraction (HFrEF) by the FDA in 2021 further broadens its therapeutic landscape [4]. These endorsements propel sales and expand the patient base.

Competitive Landscape

JARDIANCE faces competition primarily from other SGLT2 inhibitors—including AstraZeneca’s Forxiga (dapagliflozin) and Boehringer Ingelheim’s own Steglatro (ertugliflozin)—and GLP-1 receptor agonists like Lilly’s Trulicity. Its CV benefits confer a competitive edge, especially amidst increasing prescriber preference for drugs with cardio-renal protection.

Financial Trajectory

Revenue Growth

Since its launch, JARDIANCE has experienced robust revenue growth, driven by expanding indications, increased adoption, and aggressive global commercialization strategies. The drug generated approximately $3.4 billion in worldwide sales in 2022, representing a 20% YoY increase [5].

Market Penetration and Forecast

In the U.S., JARDIANCE commands a significant market share within the SGLT2 segment, particularly among high-risk patients. Analysts project that revenues could approach $5 billion annually within the next three years, assuming continued uptake, new formulation launches, and expanding indications such as heart failure [6].

Pricing Strategies and Reimbursement

Boasting premium pricing driven by CV benefits and renal protection, JARDIANCE’s cost per treatment course in the U.S. exceeds $400 monthly, with reimbursement largely facilitated by insurers. Value-based pricing models linked to CV outcome improvements bolster revenue streams and warrant ongoing negotiations with payers.

Pipeline and Growth Opportunities

Boasting a strong pipeline, Boehringer Ingelheim is developing combination therapies and exploring indications in chronic kidney disease and heart failure. The recent approval for HFrEF signifies potential to maintain revenue momentum, as off-label expansion can accelerate market penetration.

Challenges Impeding Growth

Despite promising prospects, challenges include patent cliffs—expected around 2030—and potential biosimilar competition post-patent expiry. Moreover, label limitations and safety concerns such as ketoacidosis and genital infections necessitate vigilant promotion and pharmacovigilance.

Market Dynamics Influencing Financial Trajectory

Pharmacoeconomic Trends

Increasing emphasis on value-based care shapes drug reimbursement policies. JARDIANCE’s demonstrated CV and renal benefits position it favorably as healthcare systems prioritize cost-effective management of T2DM and associated comorbidities.

Regulatory Evolution

Expedited approvals and expanding indications support revenue growth. However, regulatory scrutiny on safety profiles may impact marketing strategies and pricing.

Healthcare Provider and Patient Acceptance

Awareness programs, clinician education, and positive real-world evidence (RWE) bolster acceptance. Patient adherence remains essential, influenced by side effect profile, dosing convenience, and perceived clinical benefits.

Market Access and Competitive Strategies

Strategic partnerships, market exclusivity, and direct-to-patient marketing influence penetration. Collaborations with payers for patient assistance programs can mitigate access barriers.

Conclusion

JARDIANCE’s market dynamics are shaped by its innovative CV and renal benefits amid a burgeoning global diabetes epidemic. Its financial trajectory is poised for continued growth, supported by robust clinical data, expanding indications, and strategic market positioning. Nevertheless, competition, safety considerations, and patent timelines will influence long-term sustainability. Stakeholders must navigate these factors astutely to capitalize on JARDIANCE’s therapeutic and economic potential.

Key Takeaways

• The expanding global diabetes burden and increasing recognition of CV and renal endpoints drive JARDIANCE’s market growth.
• Its dual cardio-metabolic profile positions it as a preferred treatment, fostering strong sales momentum.
• Revenue is projected to grow sustainably, supported by approvals for additional indications and global market expansion.
• Patent expirations and competitive pressure present long-term challenges requiring strategic innovation and pipeline expansion.
• Emphasizing value-based care and leveraging real-world evidence will be critical for maintaining market share and financial success.

FAQs

1. What distinguishes JARDIANCE from other SGLT2 inhibitors in the market?
JARDIANCE offers robust evidence of cardiovascular and renal benefits, backed by landmark trials like EMPA-REG OUTCOME, which sets it apart from competitors primarily focused on glycemic control.

2. How significant are JARDIANCE’s revenues within the global diabetes market?
JARDIANCE’s revenues surpassed $3.4 billion in 2022, accounting for a substantial segment of the SGLT2 inhibitor market, with growth fueled by FDA approvals for heart failure and expanding indications.

3. What are the major risks affecting JARDIANCE’s market sustainability?
Patent expiration around 2030, increasing competition, safety concerns, and evolving regulatory landscapes pose potential risks to its long-term market dominance.

4. How do regulatory approvals influence JARDIANCE’s financial trajectory?
Regulatory endorsements, especially for heart failure and kidney disease, expand the drug’s indications, leading to increased prescribing opportunities and revenue streams.

5. What strategies can stakeholders employ to maximize JARDIANCE’s market potential?
Stakeholders should focus on clinical evidence dissemination, payer engagement for favorable reimbursement, pipeline development, and global market expansion to bolster market share.

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Sources

[1] IDF Diabetes Atlas, 9th Edition, 2019.
[2] Zinman B., et al. EMPA-REG OUTCOME Investigators. N Engl J Med. 2015.
[3] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[4] U.S. Food and Drug Administration. Press Release, 2021.
[5] Boehringer Ingelheim Annual Report, 2022.
[6] MarketWatch, 2023.