Empagliflozin - Generic Drug Details

What are the generic 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:	444
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
Beacon Pharmaceuticals PLC	PHASE2
Chittagong Medical College	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	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No					Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-002	Aug 1, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No					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
Lithuania	2981271
Taiwan	200635599	Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture
Japan	6431959
Australia	2014247092	Therapeutic uses of empagliflozin
Hong Kong	1213818	依帕列淨的治療用途 (THERAPEUTIC USES OF EMPAGLIFLOZIN)
Japan	7625363

Supplementary Protection Certificates for empagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	SPC/GB14/070	United Kingdom		PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF; REGISTERED: UK EU/1/14/930/001 - 20140527; UK EU/1/14/930/018 20140527
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
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	568	Finland
1730131	62/2014	Austria		PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014

Market Dynamics and Financial Trajectory for Empagliflozin

Last updated: December 29, 2025

Executive Summary

Empagliflozin, marketed under brands like Jardiance, is a leading SGLT2 inhibitor primarily indicated for type 2 diabetes mellitus (T2DM), heart failure, and chronic kidney disease (CKD). Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, empagliflozin has transformed treatment paradigms, contributing to significant revenue streams for its manufacturer, Boehringer Ingelheim and Eli Lilly. This article critically evaluates the current market landscape, growth drivers, competition, regulatory landscape, and future financial projections for empagliflozin, with insights into its evolving pipeline and expanding therapeutic indications.

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1. Market Overview and Key Drivers

Global Diabetes and Cardiovascular Markets

• Diabetes prevalence: Estimated at 537 million adults globally in 2021, projected to reach 700 million by 2045 ([1]).
• Cardiovascular disease: Heart failure affects approximately 64 million worldwide, with a rising incidence in aging populations ([2]).
• CKD: Affects over 850 million globally, often co-morbid with diabetes and hypertension ([3]).

Empagliflozin’s Therapeutic Niche

• Primary indications:

  • T2DM
  • Heart failure with reduced ejection fraction (HFrEF)
  • CKD

• Approved labels:

  • FDA: T2DM, HFrEF (2021), CKD (2021)
  • EMA: Similar indications, expanding use.

• Advantages driving market uptake:

  • Cardiovascular (CV) and renal protective effects
  • Once-daily oral dosing
  • Favorable safety profile

Market Growth Factors

Factor	Impact	Source/Notes
Rising T2DM prevalence	Expands potential patient base	[1]
Expanded indications (heart failure, CKD)	Significant revenue boost	[2], [3]
Increased awareness of CV and renal benefits	Accelerates prescription rates	Clinical trial data
Favorable reimbursement policies	Enhances accessibility	Varies by region
Patent protections	Market exclusivity until 2030s	Patent data

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2. Competitive Landscape and Key Players

Market Share Breakdown (2022)

Company	Product	Indications	Estimated Market Share	Notes
Boehringer Ingelheim & Lilly	Jardiance (Empagliflozin)	T2DM, HFrEF, CKD	~70%	Leading position with multiple label expansions
Pfizer	Dapagliflozin (Farxiga)	Similar indications	~20%	Strong competitor, expanding into CV/renal areas
AstraZeneca	dapagliflozin (for other indications)	Additional CV/renal indications	<5%	Rapid growth in specific markets
Others	-	-	<5%	Including remogliflozin, canagliflozin

Key Competitive Differentiators

Aspect	Empagliflozin	Dapagliflozin	Canagliflozin
CV outcomes	Landmark trials	Comparable	Similar
Patent status	Until approx. 2030	Similar	Similar
Indication scope	Broad CV and renal	Broad CV and renal	Similar
Safety profile	Favorable	Similar	Slightly higher risk of amputations

Clinical Trials & Ongoing Studies

• EMPEROR-REDUCED & EMPEROR-PRESERVED: Demonstrate benefits in heart failure.
• EMPASKIN: Investigating in dermatological disorders.
• RENAL-OUTCOMES: Ongoing studies aiming to expand renal indications.

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3. Regulatory Pathways & Policy Environment

FDA and EMA Approvals

• 2014: FDA approval for T2DM.
• 2019-2021: Label expansion to include heart failure and CKD.
• 2024: Anticipated approvals in additional indications, pending trial outcomes.

Pricing & Reimbursement Trends

Region	Reimbursement Status	Impact	Remarks
United States	Varies by insurer	Revenue stability	Medicare/Medicaid coverages expanding
European Union	Reimbursement in major markets	High adoption	Payer negotiations ongoing
Asian Markets	Rapid adoption	Potential growth	Price controls and insurance schemes vary

Policy Challenges

• Cost-effectiveness debates: Especially in lower-income regions.
• Off-label use risks: Regulatory scrutiny may impact innovation.
• Patent Cliff: Approaching patent expiry (~2030), risking generic infiltration.

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4. Financial Trajectory & Revenue Forecast

Historical Financials (2019-2022)

Year	Global Sales (USD Billion)	Growth Rate	Notes
2019	2.1	N/A	Launch phase
2020	2.75	31%	Steady uptake
2021	3.4	24%	Expanded indications
2022	4.1	21%	CV/renal market growth

Forecast Assumptions (2023-2027)

Assumption	Details	Data Source
CAGR	20-25% driven by new indications	Company guidance, market trends
Market expansion	Emerging markets growth	IMS Health, IQVIA data
Patent protection	Until 2030	Patent filings & approvals

Projected Revenue (2027)

Year	Estimated Global Sales	Notes
2027	USD 10.8 – 13.0 Billion	Assuming a conservative CAGR of 22%

Key Revenue Drivers

• Increased adoption in heart failure and CKD.
• Pricing strategies and expansion into untapped markets.
• Pipeline success: New formulations and combination products.

Major Risks & Challenges

Risk	Impact	Mitigation Strategies
Patent expiry	Generic competition	Patent extensions, lifecycle management
Regulatory delays	Market entry barriers	Early engagement, robust trial data
Market saturation	Slowing growth	Innovation, new indications

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5. Future Outlook and Emerging Opportunities

Pipeline and Indication Expansion

Development Stage	Candidate	Indication	Expected Launch	Strategic Impact
Phase III	EMPA-KIDNEY	CKD in non-diabetics	2025	Broadens market scope
Phase II	EMPA-PORT	Pulmonary hypertension	2026	Explores new areas

Potential Market Size in Emerging Indications

Indication	Estimated Patient Pool	Market Potential (USD Billions)	Rationale
Heart failure with preserved EF	26 million	$12B	Robust clinical benefits
Non-diabetic CKD	80 million	$15B	Expanding regulatory approvals

Strategic Opportunities

• Partnerships with healthcare providers to improve access.
• Combination therapies (e.g., with GLP-1 receptor agonists).
• Digital health integration for adherence and monitoring.

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Key Takeaways

• Empagliflozin is at the forefront of SGLT2 inhibitor therapies, with substantial market share driven by its broad indications and positive clinical outcomes.
• The expanding therapeutic scope (heart failure, CKD, potential additional indications) sustains strong revenue growth projections.
• Patent protections until approximately 2030 provide a window for maximum profitability; however, impending patent cliffs necessitate innovation strategies.
• Regulatory support and reimbursement policies are favorable but vary regionally, influencing global sales.
• Competitive dynamics favor consistent investment in clinical trials, pipeline expansion, and strategic partnerships to sustain market dominance.
• Forecasted revenues project a compound annual growth rate (CAGR) of approximately 20-25%, with potential to reach USD 11-13 billion by 2027.

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FAQs

Q1: How does empagliflozin compare to other SGLT2 inhibitors regarding market share?
Empagliflozin maintains a leading position, with approximately 70% of the SGLT2 inhibitor market, driven by its extensive indication portfolio and superior clinical trial data. Dapagliflozin follows with about 20%.

Q2: What are the main regulatory hurdles for empagliflozin’s future expansion?
Major hurdles include obtaining approvals for non-diabetic CKD and heart failure indications, which depend on rigorous phase III trial results. Regulatory agencies like FDA and EMA are supportive but demand robust evidence.

Q3: What is the outlook regarding patent expirations?
Patents for empagliflozin are expected to expire around 2030, opening opportunities for generics, which could impact revenues unless lifecycle management strategies are employed.

Q4: How significant is the potential for empagliflozin in treating heart failure?
Clinical trials (e.g., EMPEROR series) demonstrate significant reductions in CV mortality and hospitalization, positioning empagliflozin as a cornerstone therapy for HFrEF, expanding its revenue potential.

Q5: What are the key risks that could impact empagliflozin’s financial trajectory?
Key risks include patent cliff, market saturation, regulatory delays, off-label use restrictions, and competitive proliferation of newer agents or biosimilars.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
[2] Ponikowski, P. et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 2016.
[3] Mills, K. T. et al. Global disparities of chronic kidney disease. Kidney International Supplements, 2015.
[4] Company Financial Reports and Press Releases (Boehringer Ingelheim, Eli Lilly), 2019-2022.
[5] IQVIA Institute Reports, 2022.