EMPAGLIFLOZIN - Generic Drug Details

What are the generic drug sources for empagliflozin and what is the scope of freedom to operate?

Empagliflozin is the generic ingredient in seven branded drugs marketed by Zydus Pharms and Boehringer Ingelheim, and is included in seven NDAs. There are thirty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin has three hundred and seventy-eight patent family members in forty-six countries.

There are twenty-two drug master file entries for empagliflozin. Four suppliers are listed for this compound. There are seventeen tentative approvals for this compound.

Summary for EMPAGLIFLOZIN

International Patents:	378
US Patents:	30
Tradenames:	7
Applicants:	2
NDAs:	7
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	439
Patent Applications:	3,864
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN
What excipients (inactive ingredients) are in EMPAGLIFLOZIN?	EMPAGLIFLOZIN excipients list
DailyMed Link:	EMPAGLIFLOZIN at DailyMed

Recent Clinical Trials for EMPAGLIFLOZIN

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

Sponsor	Phase
Larry W. Markham	PHASE1
Centre Hospitalier Universitaire de Nice	PHASE4
University of Illinois at Chicago	PHASE2

See all EMPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
		25MG;5MG	TABLET;ORAL
		25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EMPAGLIFLOZIN

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

Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN

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

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 EMPAGLIFLOZIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	11,090,323*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	11,033,552*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes	11,666,590
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No	9,949,997*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	12,115,179*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	11,833,166*PED				Y

EU/EMA Drug Approvals for EMPAGLIFLOZIN

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 EMPAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Slovenia	2187879
Australia	2014247092	Therapeutic uses of empagliflozin
Japan	6574231
China	105377266
Argentina	077512	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS, SU APLICACION Y PROCEDIMIENTO PARA SU PREPARACION
Hungary	S1700020
Denmark	2986304

Supplementary Protection Certificates for EMPAGLIFLOZIN

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 EMPAGLIFLOZIN

Last updated: October 17, 2025

Introduction

Empagliflozin, marketed under the brand name Jardiance among others, is a groundbreaking pharmaceutical product classified as an SGLT2 (sodium-glucose co-transporter 2) inhibitor. Since its approval, it has significantly impacted the management of type 2 diabetes mellitus (T2DM) and associated cardiovascular and renal comorbidities. This report explores the current market landscape, driving factors, competitive positioning, regulatory influences, and the financial trajectory shaping empagliflozin's future prospects.

Market Overview and Growth Drivers

The global diabetes therapeutics market exceeded USD 80 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of approximately 7% through 2030 [1]. Empagliflozin constitutes a significant segment within this space, owing to its multifaceted therapeutic profile—glycemic control, cardiovascular risk reduction, and renal protection. The drug's dual benefits—for both glycemic management and cardio-renal outcomes—have expanded its indications beyond initial approval, cementing its position in a lucrative and expanding market.

Key growth drivers include:

• Rising Global Diabetes Prevalence: The IDF reports over 537 million adults with diabetes worldwide in 2021; this number is expected to reach 643 million by 2030 [2]. The increasing burden fuels demand for effective, multi-indication therapies like empagliflozin.

• Cardiovascular and Renal Benefits: Landmark trials such as EMPA-REG OUTCOME demonstrated a 38% reduction in cardiovascular death and a 35% reduction in hospitalization for heart failure among T2DM patients treated with empagliflozin [3]. These findings have shifted prescribing paradigms, positioning the drug as a preferred therapy in high-risk populations, thus bolstering market penetration.

• Expanding Label Approvals and Indications: Regulatory bodies have approved empagliflozin for multiple uses, including heart failure with reduced ejection fraction and chronic kidney disease, even in non-diabetic patients [4]. These broadened indications substantially expand market potential.

• Increasing Adoption in Developed and Emerging Markets: While adoption is well-established in North America and Europe, increased access and healthcare investments in Asia-Pacific (APAC) and Latin America support growth trajectories.

Competitive Landscape

Empagliflozin faces competition primarily from other SGLT2 inhibitors, including canagliflozin (Invokana), dapagliflozin (Farxiga), and ertugliflozin (Steglatro). Differentiation hinges on clinical efficacy, cardiovascular and renal benefits, safety profiles, and formulary preferences.

• Efficacy and Safety: EMPA-REG outcomes demonstrated superior cardiovascular benefits relative to some competitors, positioning empagliflozin favorably [3].

• Brand Recognition and Partnerships: Boehringer Ingelheim and Eli Lilly co-developed empagliflozin, leveraging established relationships and global marketing networks.

• Investment in Novel Indications: The pursuit of approvals for non-diabetic conditions representing significant unmet medical needs, particularly HFpEF (heart failure with preserved ejection fraction), enhances competitive positioning.

Market Challenges and Regulatory Environment

Despite its promising trajectory, empagliflozin faces regulatory and market challenges:

• Safety Concerns: Risks of urinary tract infections, ketoacidosis, and rare cases of Fournier’s gangrene continue to influence prescribing patterns and regulatory scrutiny [5].

• Pricing and Reimbursement Dynamics: Variability in pharmacoeconomic assessments across markets influences pricing strategies and market access. Payers favor cost-effective options, especially in resource-constrained settings.

• Patent Expiry and Generic Competition: Although empagliflozin’s patents are current, imminent exclusivity expiration could introduce generic competitors, exerting downward pressure on prices.

• Market Saturation and Physician Adoption: Slow uptake in certain regions due to clinical inertia, safety concerns, or alternative therapies presents barriers to growth, particularly outside flagship indications.

Financial Trajectory and Revenue Outlook

Empagliflozin’s revenue performance reflects its clinical success and expanding indications:

• Historical Sales Performance: In 2022, Eli Lilly and Boehringer Ingelheim reported global sales exceeding USD 5 billion for Jardiance, marking it among top-tier diabetes drugs [6].

• Projected Growth: Considering the expanding indication portfolio, ongoing clinical trials, and increasing global prevalence, revenues are projected to grow at a CAGR of approximately 8-10% through 2028.

• Impact of New Indications: The FDA and EMA approvals for heart failure and chronic kidney disease could contribute an estimated USD 2–3 billion in incremental annual revenues within the next five years.

• Market Penetration Strategies: Launch initiatives targeting emerging markets, payer negotiations, and patient-centric digital health programs are expected to bolster sales trajectories.

• Pricing Strategies: Premium pricing remains feasible in high-income markets, but price erosion due to generics, especially upon patent expiry, necessitates diversified revenue streams and cost management.

Future Outlook and Strategic Considerations

Empagliflozin’s future growth hinges on several strategic factors:

• Continued Clinical Trials: Positive outcomes from trials such as EMPA-KIDNEY and DELIVER will cement its role in broader cardiorenal care.

• Regulatory Approvals in New Populations: Approvals for non-diabetic heart failure and CKD patients are anticipated, expanding the patient base.

• Innovation and Combination Therapies: Development of fixed-dose combinations and adjunctive therapies may enhance adherence and effectiveness, supporting market share.

• Market Expansion and Education: Increasing awareness among physicians and patients, especially in emerging markets, can turbocharge growth.

Conclusion

Empagliflozin’s market dynamics are characterized by a confluence of increasing global demand for effective diabetes and cardiovascular therapies, expanding clinical indications, and strategic market positioning. The drug’s financial trajectory appears robust, with substantial potential for growth driven by ongoing clinical validation, favorable regulatory evolutions, and targeted market expansion. However, challenges such as pricing pressures, safety considerations, and eventual patent expiration must be proactively managed to sustain long-term profitability.

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Key Takeaways

• Empagliflozin remains a leading SGLT2 inhibitor with substantial growth potential, driven by its proven cardiovascular and renal benefits.

• The expanding scope of approvals beyond glycemic control into diverse cardiorenal indications substantially broadens its market.

• Competitive advantages stem from clinical trial outcomes, brand collaborations, and strategic indication expansion.

• Market challenges include safety concerns, regulatory scrutiny, reimbursement variances, and impending patent expirations.

• Financial growth is projected to sustain at high single digits to low double digits CAGR, contingent on successful clinical trials, regulatory approvals, and market access strategies.

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FAQs

1. What are the primary indications for empagliflozin?
   Originally approved for type 2 diabetes mellitus, empagliflozin is now indicated for cardiovascular risk reduction in T2DM and, more recently, for treating heart failure and certain kidney diseases regardless of diabetic status [4].

2. How does empagliflozin compare to other SGLT2 inhibitors?
   Clinical trials like EMPA-REG OUTCOME demonstrate superior cardiovascular benefits relative to some competitors, bolstering its preferred status in high-risk populations [3].

3. What are the main market challenges facing empagliflozin?
   Safety concerns, pricing pressures, regulatory scrutiny, patent expiration, and regional disparities in adoption pose ongoing hurdles.

4. What is the projected revenue growth for empagliflozin over the next five years?
   With expanding indications and market penetration, revenues are expected to grow at a CAGR of approximately 8–10%, reaching USD 8–10 billion globally by 2028 [6].

5. What strategic actions can enhance empagliflozin’s market position?
   Securing new regulatory approvals, investing in clinical research, expanding into emerging markets, and developing combination formulations are key strategies.

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Sources

[1] Grand View Research, "Diabetes Drugs Market Size & Trends," 2022.
[2] International Diabetes Federation, "IDF Diabetes Atlas," 2021.
[3] Zinman B, et al. "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes," NEJM, 2015.
[4] U.S. Food & Drug Administration, "Jardiance Label," 2022.
[5] FDA Drug Safety Communications, "SGLT2 Inhibitors and Rare Cases of Necrotizing Fasciitis," 2018.
[6] Eli Lilly & Boehringer Ingelheim, "Jardiance Sales Report," 2022.