JARDIANCE Drug Patent Profile

Which patents cover Jardiance, and when can generic versions of Jardiance launch?

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

This drug has four hundred and twenty-four 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 eighteen 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:	424
US Patents:	15
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JARDIANCE

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 fifteen US patents and three 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

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
Portugal	2981255
Chile	2011001735
European Patent Office	3456332	UTILISATIONS THÉRAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN)

Supplementary Protection Certificates for JARDIANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	92555	Luxembourg		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014

JARDIANCE: Investment Fundamentals and Market Landscape

Last updated: February 19, 2026

What Is JARDIANCE and What Is Its Approved Indication?

JARDIANCE, the brand name for empagliflozin, is an oral medication developed by Boehringer Ingelheim and Eli Lilly and Company. It is a sodium-glucose cotransporter-2 (SGLT2) inhibitor. Its primary mechanism of action involves inhibiting SGLT2 in the kidneys, which reduces glucose reabsorption and promotes urinary glucose excretion, thereby lowering blood glucose levels in individuals with type 2 diabetes (T2D) [1, 2].

JARDIANCE is approved for:

• Glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise [1].
• Reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) [3].
• Reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, with or without type 2 diabetes [4].

What Is the Market Opportunity for JARDIANCE?

The market opportunity for JARDIANCE is substantial, driven by the global prevalence of type 2 diabetes, cardiovascular disease, and heart failure.

Epidemiological Data:

• Globally, over 537 million adults were living with diabetes in 2021. This number is projected to reach 643 million by 2030 and 783 million by 2045 [5].
• Type 2 diabetes accounts for approximately 90-95% of all diabetes cases [5].
• Cardiovascular disease is the leading cause of death globally, and diabetes is a significant risk factor [6].
• Heart failure affects an estimated 64 million people worldwide [7].

Market Size and Growth: The global SGLT2 inhibitor market, including JARDIANCE, is expanding due to the demonstrated cardiovascular and renal benefits of this drug class, extending beyond glycemic control.

• The global market for SGLT2 inhibitors was valued at approximately USD 13.1 billion in 2022 and is projected to grow to USD 26.1 billion by 2030, with a compound annual growth rate (CAGR) of 9.0% during the forecast period [8].
• JARDIANCE holds a significant share of this market. In 2022, its net sales were approximately USD 5.9 billion [9].

The expanded indications for cardiovascular risk reduction and heart failure management have significantly broadened JARDIANCE's addressable market, capturing patients beyond those solely managing blood glucose.

What Are JARDIANCE's Key Clinical Trial Data and Efficacy Metrics?

JARDIANCE's clinical success is anchored by robust data from major clinical trials, particularly the EMPEROR and EMPA-REG OUTCOME studies.

EMPA-REG OUTCOME Study:

• This trial evaluated JARDIANCE in adults with T2D and established CVD.
• Primary Composite Endpoint: Reduced the risk of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke by 14% compared to placebo (Hazard Ratio [HR] 0.86; 95% CI 0.74-0.99; p=0.038) [3].
• Key Secondary Endpoint (Cardiovascular Death): Reduced the risk of cardiovascular death by 38% compared to placebo (HR 0.62; 95% CI 0.49-0.77; p<0.001) [3].
• Renal Outcomes: Showed a significant reduction in the progression of kidney disease [3].

EMPEROR-Reduced Study:

• This trial investigated JARDIANCE in adults with heart failure with reduced ejection fraction (HFrEF), irrespective of diabetes status.
• Primary Composite Endpoint: Reduced the risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo (HR 0.75; 95% CI 0.65-0.86; p<0.001) [4].
• Components of the Endpoint:
  • Hospitalizations for heart failure were reduced by 30% (HR 0.70; 95% CI 0.58-0.85; p<0.001) [4].
  • Cardiovascular death showed a trend towards reduction but did not reach statistical significance as a standalone component within this specific primary analysis [4].

EMPEROR-Preserved Study:

• This trial assessed JARDIANCE in adults with heart failure with preserved ejection fraction (HFpEF), irrespective of diabetes status.
• Primary Composite Endpoint: Reduced the risk of cardiovascular death or hospitalization for heart failure by 21% compared to placebo (HR 0.79; 95% CI 0.69-0.90; p=0.001) [10].
• Key Findings:
  • Hospitalizations for heart failure were reduced by 18% (HR 0.82; 95% CI 0.71-0.95; p=0.007) [10].
  • This study marked a significant breakthrough, as it was the first trial to demonstrate a benefit for this patient population [10].

Glycemic Efficacy: JARDIANCE consistently demonstrates clinically meaningful reductions in HbA1c levels in patients with T2D.

• In clinical trials, JARDIANCE typically lowered HbA1c by 0.7% to 1.0% compared to placebo when used as monotherapy or in combination with other oral antidiabetics [1, 11].

What Is the Intellectual Property (IP) Landscape for JARDIANCE?

The patent protection for JARDIANCE is critical to its long-term commercial viability.

Core Composition of Matter Patent: The foundational patent covering empagliflozin is expected to expire in many major markets in the late 2020s.

• US Patent Expiration (estimated): While specific expiry dates are complex and subject to extensions, the core US patent protection for empagliflozin has been reported to expire around 2027-2028.
• European Patent Expiration (estimated): Similar timelines are observed in Europe, with potential expiry in the 2027-2028 timeframe, subject to Supplementary Protection Certificates (SPCs).

Formulation and Method of Use Patents: Boehringer Ingelheim and Eli Lilly also hold a portfolio of secondary patents covering specific formulations, manufacturing processes, and methods of use for JARDIANCE. These patents can extend exclusivity by preventing generic manufacturers from launching products that infringe on these later-filed patents.

• These secondary patents often cover specific crystalline forms, synergistic combinations with other drugs, and novel delivery mechanisms.
• The expiry of these secondary patents will vary, with some extending into the early to mid-2030s.

Patent Challenges and Litigation: As patent expiry approaches, the threat of patent litigation and challenges from generic manufacturers increases.

• Generic companies typically seek to invalidate or design around existing patents to gain market entry.
• The strength and breadth of the patent portfolio, along with any ongoing litigation, are key factors in assessing the duration of market exclusivity.

Impact of Exclusivity Loss: Upon the expiry of primary patents and successful navigation of secondary patents by generic competitors, JARDIANCE would face significant price erosion and loss of market share, a common trajectory for blockbuster drugs in the pharmaceutical industry.

What Is the Competitive Landscape for JARDIANCE?

JARDIANCE operates within a dynamic and competitive therapeutic landscape, primarily defined by other SGLT2 inhibitors and emerging drug classes for diabetes and heart failure.

Direct Competitors (SGLT2 Inhibitors): The SGLT2 inhibitor class has several major players, each with its own clinical data and market positioning.

• Forxiga (dapagliflozin) by AstraZeneca:

  • Approved for T2D, CVD risk reduction, and heart failure (both reduced and preserved ejection fraction).
  • Has demonstrated significant CV and renal benefits, mirroring JARDIANCE's expanded indications [12].
  • A major competitor with similar market penetration and growth trajectories.

• Invokana (canagliflozin) by Johnson & Johnson:

  • Approved for T2D and established CVD risk reduction.
  • Also shows CV and renal benefits, though its indication for HFrEF is not as broad as JARDIANCE or Forxiga [13].
  • Faces patent challenges and generic competition in some markets.

• Steglatro (ertugliflozin) by Merck & Co.:

  • Approved for T2D.
  • Has shown efficacy in reducing HbA1c and has some CV data, but its market share and expanded indications are less developed compared to the top-tier SGLT2 inhibitors [14].

Indirect Competitors and Emerging Therapies:

• GLP-1 Receptor Agonists (GLP-1 RAs): Drugs like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) have shown robust efficacy in glycemic control, weight loss, and significant cardiovascular benefits, posing a substantial competitive threat, especially in the T2D market [15].
• DPP-4 Inhibitors: While older, these remain a part of the T2D treatment landscape.
• Insulin Therapies: Continue to be essential for many patients, particularly in later stages of T2D or for type 1 diabetes.
• Other Cardiovascular Therapies: In the heart failure space, JARDIANCE competes with established treatments like ACE inhibitors, ARBs, beta-blockers, and mineralocorticoid receptor antagonists (MRAs), as well as newer agents like ARNIs (sacubitril/valsartan).

Competitive Advantages of JARDIANCE:

• Established CV and HF Indications: The breadth of approved indications for cardiovascular risk reduction and heart failure management (both HFrEF and HFpEF) is a key differentiator.
• Strong Clinical Data: The EMPEROR and EMPA-REG OUTCOME trials provide a solid foundation of evidence supporting its benefits.
• Market Penetration: As one of the earlier entrants with broad indications, JARDIANCE has established a significant market presence.

The competitive landscape necessitates continuous innovation and evidence generation to maintain market share, particularly as patent expiries loom and new therapeutic modalities emerge.

What Are the Financial Performance and Sales Trends for JARDIANCE?

JARDIANCE has demonstrated strong and consistent sales growth, establishing it as a blockbuster drug for Boehringer Ingelheim and Eli Lilly.

Net Sales Growth:

• 2022: Net sales for JARDIANCE reached approximately USD 5.9 billion globally [9].
• 2021: Net sales were approximately USD 4.7 billion [16].
• 2020: Net sales were approximately USD 3.5 billion [17].

This represents substantial year-over-year growth, driven by the expanding indications and market adoption of SGLT2 inhibitors for their cardiovascular and renal benefits.

Key Sales Drivers:

• US Market: The United States typically represents the largest market for JARDIANCE, benefiting from broad physician acceptance and reimbursement.
• Ex-US Markets: Sales in Europe and other international markets are also growing robustly.
• Expanded Indications: The approvals for reducing cardiovascular death in T2D patients with established CVD and for treating heart failure (both HFrEF and HFpEF) have been critical growth catalysts. These indications allow JARDIANCE to be prescribed to a much wider patient population.
• Physician and Patient Awareness: Increased awareness and understanding of the multifaceted benefits of SGLT2 inhibitors beyond glycemic control contribute to uptake.

Financial Contributions to Parent Companies:

• Eli Lilly and Company: JARDIANCE is a significant contributor to Eli Lilly's revenue portfolio. In 2022, its sales accounted for a substantial portion of Lilly's total revenue from its diabetes products.
• Boehringer Ingelheim: For the privately held Boehringer Ingelheim, JARDIANCE is a flagship product driving its cardiovascular and diabetes franchise.

The sustained growth trajectory of JARDIANCE positions it as a key asset for its developers, though future performance will be influenced by patent expirations and competitive pressures.

What Are the Risks and Opportunities for JARDIANCE Investors?

Investing in JARDIANCE, like any pharmaceutical asset, presents a mix of potential rewards and inherent risks.

Opportunities:

• Continued Market Growth: The global diabetes and heart failure markets continue to expand due to aging populations and lifestyle factors, providing a tailwind for JARDIANCE.
• Real-World Evidence and New Data: Ongoing research and real-world evidence generation can uncover further benefits or refine its use in specific patient populations, potentially expanding its label or strengthening its market position.
• Emerging Markets Penetration: Growth in developing economies where the prevalence of T2D and CVD is rising presents significant untapped potential.
• Combination Therapies: Development and approval of fixed-dose combination products involving empagliflozin could simplify treatment regimens and enhance market adoption.

Risks:

• Patent Expiration and Generic Competition: This is the most significant risk. The expiry of core composition of matter patents will inevitably lead to the introduction of generic empagliflozin, resulting in substantial price erosion and market share decline. The exact timing and impact will depend on the strength of secondary patents and generic entry strategies.
• Intensifying Competition: The SGLT2 inhibitor class remains competitive, and newer drug classes like GLP-1 RAs with prominent CV benefits are posing increasing competition, particularly for T2D management.
• Regulatory Scrutiny and Safety Concerns: Like all medications, JARDIANCE is subject to ongoing safety monitoring. Unexpected adverse events or regulatory actions could negatively impact its market.
• Reimbursement Pressures: Healthcare systems globally face cost containment pressures, which could lead to tighter reimbursement policies for established drugs, affecting pricing and access.
• Clinical Trial Failures for New Indications: If future clinical trials aimed at expanding JARDIANCE's indications were to fail, it would limit its growth potential.

Investor Considerations: Investors need to closely monitor patent expiry dates, litigation outcomes, the trajectory of competitive products, and the evolving regulatory and reimbursement landscape. The peak sales potential of JARDIANCE is largely realized, and its future value will be increasingly influenced by its lifecycle management and the ability of its developers to strategically navigate the post-patent cliff.

Key Takeaways

JARDIANCE (empagliflozin) is a leading SGLT2 inhibitor with significant market traction driven by its approved indications for type 2 diabetes glycemic control, cardiovascular risk reduction in T2D patients with established CVD, and heart failure management (both reduced and preserved ejection fraction). Robust clinical trial data from EMPA-REG OUTCOME and EMPEROR trials supports its efficacy and safety profile across these broad indications. The drug has achieved blockbuster status, with global net sales exceeding USD 5.9 billion in 2022. However, its long-term investment thesis is heavily influenced by upcoming patent expirations, primarily in the late 2020s, which will introduce generic competition and lead to price erosion. The competitive landscape is intense, with other SGLT2 inhibitors and emerging drug classes like GLP-1 RAs posing ongoing challenges.

Frequently Asked Questions

1. What is the projected impact of JARDIANCE's patent expiration on its sales? Patent expirations in major markets, expected around 2027-2028 for core patents, will lead to the introduction of generic empagliflozin. This is projected to cause a substantial decline in JARDIANCE's net sales, following a typical pattern for blockbuster drugs. The magnitude of this decline will depend on the success of secondary patents and the speed of generic market entry.

2. How does JARDIANCE differentiate itself from other SGLT2 inhibitors like Forxiga? JARDIANCE's differentiation lies in the breadth of its approved indications and the strength of its supporting clinical data. It holds significant approvals for cardiovascular death reduction in T2D with established CVD and for both HFrEF and HFpEF, which are key market advantages. While Forxiga also has broad indications, the specific clinical outcomes and physician perception can create nuances in market positioning.

3. What are the primary risks associated with investing in JARDIANCE at this stage of its lifecycle? The primary risks include the impending expiry of key patents leading to generic competition, intensified competition from other SGLT2 inhibitors and novel drug classes (e.g., GLP-1 RAs), potential regulatory scrutiny or adverse event findings, and evolving reimbursement policies that could impact pricing and market access.

4. Beyond type 2 diabetes and heart failure, are there other potential indications for empagliflozin in development? Research continues into the broader therapeutic potential of SGLT2 inhibitors. While specific new indications for empagliflozin might be under investigation by the developers, focus has largely been on solidifying its position in cardiovascular and renal disease management. Any new indications would require extensive clinical trials and regulatory approval.

5. What role do real-world evidence studies play in supporting JARDIANCE's market position? Real-world evidence studies are crucial for confirming the effectiveness and safety of JARDIANCE in broader, more diverse patient populations outside of controlled clinical trials. They can provide insights into long-term outcomes, adherence rates, and cost-effectiveness, which can influence clinical practice guidelines, payer decisions, and physician prescribing habits, thereby supporting its market position and potentially informing future label expansions or value-based pricing arguments.

Citations

[1] Boehringer Ingelheim. (n.d.). JARDIANCE® (empagliflozin) tablets prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database]

[2] Wilmot, E. G., & Ralston, S. H. (2013). SGLT2 inhibitors: A new class of antidiabetic drugs. The Journal of the Royal College of Physicians of Edinburgh, 43(1), 22-27.

[3] Zinman, B., Wanner, C., Lachin, J. M., Inzucchi, S. E., Mattheus, M., Johansen, O. E., ... & Broedl, U. C. (2015). Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. New England Journal of Medicine, 373(22), 2117-2128.

[4] Packer, M., Anker, S. D., Butler, J., Filippatos, G., Januzzi, J. L., Vardeny, O., ... & Zannad, F. (2020). Cardiovascular and renal outcomes with empagliflozin in heart failure. New England Journal of Medicine, 383(15), 1413-1424.

[5] International Diabetes Federation. (2021). IDF Diabetes Atlas 10th Edition 2021. Retrieved from [IDF Website]

[6] World Health Organization. (2020). Cardiovascular diseases (CVDs). Retrieved from [WHO Website]

[7] Savarese, G., & Lund, L. H. (2017). Global public health burden of heart failure. Cardiac Failure Review, 3(1), 7-11.

[8] Grand View Research. (2023). SGLT2 Inhibitors Market Size, Share & Trends Analysis Report By Drug Type, By Indication, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Market Research Firm Website]

[9] Eli Lilly and Company. (2023). Eli Lilly and Company 2022 Annual Report. Retrieved from [Eli Lilly Investor Relations Website]

[10] Anker, S. D., Butler, J., Filippatos, G., Januzzi, J. L., Køber, L., Lam, C. S. P., ... & Packer, M. (2021). Empagliflozin in heart failure with a preserved ejection fraction. New England Journal of Medicine, 385(16), 1451-1461.

[11] Davies, M. J., & Bailey, C. J. (2015). SGLT-2 inhibitors in type 2 diabetes: a new class of glucose-lowering drug. The Journal of Clinical Endocrinology & Metabolism, 100(2), 409-412.

[12] AstraZeneca. (n.d.). Forxiga® (dapagliflozin) prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database]

[13] Johnson & Johnson. (n.d.). Invokana® (canagliflozin) prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database]

[14] Merck & Co., Inc. (n.d.). Steglatro® (ertugliflozin) prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database]

[15] Novo Nordisk. (2023). Ozempic® (semaglutide) prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database]

[16] Eli Lilly and Company. (2022). Eli Lilly and Company 2021 Annual Report. Retrieved from [Eli Lilly Investor Relations Website]

[17] Boehringer Ingelheim. (2021). Boehringer Ingelheim 2020 Annual Report. Retrieved from [Boehringer Ingelheim Corporate Website]