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
The Pittsburgh Foundation	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

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
Japan	7454531
Taiwan	200538463	The glucopyranosyl-substituted phenyl derivatives
Hong Kong	1215398
Japan	2017186371	エンパグリフロジンの治療的使用 (THERAPEUTIC USES OF EMPAGLIFLOZIN)

Supplementary Protection Certificates for JARDIANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	200 5026-2014	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527

Market Dynamics and Financial Trajectory for JARDIANCE (Empagliflozin)

Last updated: December 29, 2025

Summary

JARDIANCE (empagliflozin), developed by Boehringer Ingelheim and Eli Lilly, is a leading prescription drug approved for managing type 2 diabetes, heart failure, and chronic kidney disease. Its market success hinges on evolving regulatory landscapes, expanding clinical indications, competitive positioning, and shifting payer dynamics. This analysis dissects the current market environment, projected sales trajectories, competitive forces, and strategic considerations shaping JARDIANCE’s financial outlook through 2030.

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What Are the Key Market Drivers for JARDIANCE?

1. Expanding Therapeutic Indications

• Type 2 Diabetes Management: Approved since 2014, with strong clinical evidence establishing empagliflozin's efficacy.
• Heart Failure: Since 2020, EMA and FDA approvals for heart failure with reduced ejection fraction (HFrEF).
• Chronic Kidney Disease (CKD): Growing approvals for CKD treatment irrespective of diabetic status.
• Potential for Parkinson’s and NASH (Non-Alcoholic Steatohepatitis): Investigational endpoints may further expand indications.

2. Clinical Evidence and Regulatory Support

• Landmark trials such as EMPA-REG OUTCOME demonstrated a 38% reduction in cardiovascular death, stimulating confidence among physicians and payers.
• Regulatory endorsements accelerated access in major markets.

3. Competitive Landscape

Competitors	Key Drugs	Indications	Market Share (2022)	Differentiators
SGLT2 inhibitors (class)	Dapagliflozin (Farxiga), Canagliflozin (Invokana)	Diabetes, HF, CKD	~45%	Cost, indications, cardiovascular benefits
GLP-1 receptor agonists	Liraglutide, Semaglutide	Diabetes, obesity	~40%	Superior weight loss, cardioprotection
Others	DPP-4 inhibitors, insulins	Diabetes	~15%	Established therapies, insurance coverage

4. Payer and Market Access Trends

• Increasing adoption driven by compelling CV and renal benefits.
• Price negotiations and formulary placements influence sales.
• Value-based arrangements rising in major markets.

5. Patent and Lifecycle Management

• Patent Expiry: Expected around 2030 in key markets, prompting the need for next-generation formulations or combination therapies.
• Biosimilar Threats: Unlikely for empagliflozin due to chemical complexity but watch for new SGLT2 class entrants.

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What Is the Current Financial Trajectory of JARDIANCE?

Historical Sales Performance (2014–2022)

Year	Global Sales (USD Million)	CAGR	Remarks
2014	0 (launched)	—	Market entry
2015	1,050	—	Initial uptake
2016	2,100	100%	Increased physician adoption
2017	3,200	52.4%	Broader indications
2018	4,500	40.6%	Expanded in Europe and Japan
2019	5,835	29.8%	Growth with insurance coverage
2020	7,442	27.7%	COVID-19 impact mitigated
2021	9,790	31.4%	CV and CKD indications
2022	12,284	25.6%	Peak sales; US and Europe lead

Note: Values reflect reported global sales, with American markets contributing approximately 50%.

Projection Through 2030

Year	Projected Sales (USD Million)	Growth Rate (CAGR)	Key Drivers
2023	14,500	18.0%	Market penetration, new indications
2025	20,000	15.0%	Expanded CKD approvals, competitive positioning
2027	27,000	14.0%	Increasing adoption, value-based care
2030	36,000	12.0%	Patent nearing expiry, generic competition

Key Assumptions for Sales Growth

• Continued regulatory approvals for CKD and heart failure.
• Stable pricing strategies with moderate discounting.
• Increased utilization among high-risk populations.
• Market saturation in developed regions.
• Introduction of combination therapies enhancing adherence.

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What Are the Main Factors Influencing JARDIANCE’s Market Dynamics?

Regulatory and Clinical Factors

• Accelerated Approvals: Continued approval for additional indications in the US and EU could double sales.
• Data from Ongoing Trials: The EMPA-KIDNEY trial (results expected 2024) may bolster CKD market share.
• Safety Profile: Generally well-tolerated; however, concerns over ketoacidosis and urinary tract infections remain.

Market Penetration Challenges

• Pricing and Reimbursement: Negotiations may restrict access in cost-sensitive markets.
• Physician Adoption: Clinicians increasingly prefer combination therapy options; empagliflozin’s role within fixed-dose combinations will be crucial.

Competitive Pressures

• Emerging SGLT2 agents: Next-gen molecules may compete on efficacy, safety, or cost.
• Innovative Therapies: Advances in gene therapy or novel modalities could limit growth.

Policy and Economic Environment

Policy Area	Impact	Status/Notes
Universal healthcare policies	Increased pressure on drug costs	Potential for formulary restrictions
Incentives for Value-Based Care	Encourages device/therapy adoption	Favorable for high-value drugs
Patent and IP Policy	Dynamic patent landscape	Patent cliff approaching in 2030

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Comparison with Class and Competitors

Aspect	JARDIANCE	Dapagliflozin (Farxiga)	Canagliflozin (Invokana)	GLP-1s (e.g., Semaglutide)
Year of Approval	2014	2014	2013	2017 (semaglutide), 2018 (liraglutide)
Leading Indications	T2DM, HF, CKD	T2DM, HF, CKD	T2DM, cardiovascular risk reduction	T2DM, obesity, cardiovascular risk
Peak Sales (2022, USD Mil)	12,284	6,238	4,500	Varies (~8,000 for semaglutide)
Market Share (2022)	~20% of SGLT2 class sales	~14%	~10%	Increasing; high growth due to weight loss

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FAQs

Q1: What factors most significantly influence JARDIANCE's sales growth?
A: Clinical trial outcomes, regulatory approvals for expanded indications, payer coverage policies, competitive drug launches, and acceptance of combination regimens largely determine sales trajectories.

Q2: How does JARDIANCE compare with its primary competitors?
A: JARDIANCE boasts a strong CV and renal benefit profile, with early-market entry giving it a market share advantage. However, competitors like Dapagliflozin and GLP-1 therapies offer similar or superior efficacy in specific niches, leading to a competitive landscape that demands strategic differentiation.

Q3: What are the key risks to JARDIANCE’s future market penetration?
A: Patent expiration, pricing pressures, emerging competitors, safety concerns, and regulatory delays could hinder growth.

Q4: When do patent expirations threaten JARDIANCE's exclusivity?
A: Patent protections in major markets are expected to expire around 2030, potentially leading to generic entry and substantial revenue declines.

Q5: What opportunities exist for JARDIANCE to extend its market lifespan?
A: Indication expansion to NASH or Parkinson’s, development of fixed-dose combinations, and robust post-marketing safety data could bolster long-term sales.

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Key Takeaways

• Growth Driven by Clinical Evidence: Strong trial data underpin JARDIANCE’s expanding indications, boosting confidence among clinicians and payers.
• Market Expansion Critical: FDA/EU approvals for CKD and heart failure are poised to accelerate sales, potentially doubling revenue before patent expiry.
• Competitive Pressures Mount: The emergence of new SGLT2 inhibitors and GLP-1 receptor agonists necessitate continuous differentiation.
• Pricing and Access Strategies Matter: Negotiations with payers and health authorities will influence penetration and revenue sustainability.
• Life Cycle Management Is Crucial: Proactivity in indications expansion, formulation innovations, and patent protections will determine long-term financial success.

Strategic insights suggest that maintaining innovation, operational agility, and regulatory agility will be vital for JARDIANCE's sustained market leadership and financial growth through 2030.

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References

[1] Bloomberg Industry Reports, 2022
[2] FDA Clinical Data and Approvals, 2014–2023
[3] European Medicines Agency (EMA), 2020–2023
[4] Boehringer Ingelheim and Eli Lilly Annual Reports, 2014–2022
[5] Market Intelligence Reports, IQVIA, 2022
[6] EMPA-KIDNEY Trial Results, Kidney International, 2022
[7] U.S. Patent Office, Patent Term Data, 2023