EMPAGLIFLOZIN; LINAGLIPTIN - Generic Drug Details

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

Empagliflozin; linagliptin is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twenty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has six hundred and twenty-six patent family members in forty-eight countries.

One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for EMPAGLIFLOZIN; LINAGLIPTIN

International Patents:	626
US Patents:	23
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	38
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; LINAGLIPTIN
DailyMed Link:	EMPAGLIFLOZIN; LINAGLIPTIN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EMPAGLIFLOZIN; LINAGLIPTIN

Constraining patent/regulatory exclusivity:

8,551,957*PED

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EMPAGLIFLOZIN; LINAGLIPTIN

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Diabetes & Endocrinology Foundation	N/A
Medanta, The Medicity, India	N/A

See all EMPAGLIFLOZIN; LINAGLIPTIN clinical trials

Generic filers with tentative approvals for EMPAGLIFLOZIN; LINAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
		25MG;5MG	TABLET;ORAL
		25MG/5MG	TABLET;ORAL
		10MG/5MG	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; LINAGLIPTIN

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMPAGLIFLOZIN; LINAGLIPTIN

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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; LINAGLIPTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLYXAMBI	Tablets	empagliflozin; linagliptin	10 mg/5 mg and 25 mg/5 mg	206073	9	2018-08-01

US Patents and Regulatory Information for EMPAGLIFLOZIN; LINAGLIPTIN

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	212614-002	Jan 27, 2020		RX	Yes	No	10,022,379		Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	7,407,955*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	7,407,955*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	8,673,927*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No	10,258,637*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	8,551,957*PED				Y

Expired US Patents for EMPAGLIFLOZIN; LINAGLIPTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	6,303,661
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,119,648
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	7,459,428
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,178,541
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	6,303,661
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	6,890,898

EU/EMA Drug Approvals for EMPAGLIFLOZIN; LINAGLIPTIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Glyxambi	empagliflozin, linagliptin	EMEA/H/C/003833Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.	Authorised	no	no	no	2016-11-11

International Patents for EMPAGLIFLOZIN; LINAGLIPTIN

Country	Patent Number	Title	Estimated Expiration
Canada	2587639	DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE)
Japan	2010159305
New Zealand	550464	Glucopyranosyl-substituted benzol derivatives, drugs containing said compounds, the use thereof and method for the production thereof
Brazil	112018072401
Hong Kong	1188777	吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
Japan	7084711

Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	132017000050485	Italy		PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1532149	CA 2011 00030	Denmark
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
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...
2187879	122017000024	Germany		PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111

Market Dynamics and Financial Trajectory for Empagliflozin and Linagliptin

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape for type 2 diabetes mellitus (T2DM) management features dynamic shifts driven by innovation, regulatory changes, and market needs. Among prominent agents, empagliflozin (a sodium-glucose co-transporter-2 (SGLT2) inhibitor) and linagliptin (a dipeptidyl peptidase-4 (DPP-4) inhibitor) have garnered significant attention owing to their efficacy and evolving positioning within therapeutic guidelines. Analyzing their market dynamics and financial trajectories offers valuable insights for stakeholders navigating the competitive and regulatory environment.

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Market Overview and Growth Drivers

The diabetic medication sector is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7-9% over the next five years, driven by rising prevalence, aging populations, and increased awareness of cardiovascular and renal benefits associated with new therapies [1]. Within this landscape, SGLT2 inhibitors and DPP-4 inhibitors are key pillars, contributing substantially to market revenues.

Empagliflozin: A Market Leader in Heart and Kidney Benefits

Empagliflozin, marketed primarily as Jardiance by Boehringer Ingelheim and Eli Lilly, has distinguished itself through robust cardiovascular outcome trials, particularly the EMPA-REG OUTCOME study (2015), which demonstrated significant reductions in cardiovascular mortality and hospitalization for heart failure among T2DM patients [2]. This positioning has transformed empagliflozin from merely a glycemic agent into a multifaceted cardiovascular and renal therapy.

The drug’s expanding label indications include:

• Heart failure with reduced ejection fraction (HFrEF)
• Chronic kidney disease (CKD), regardless of diabetic status

These label expansions are projected to considerably elevate sales, especially in the U.S. and Europe, where regulatory agencies have approved these indications. The implication is an acceleration in demand from cardiologists and nephrologists, broadening empagliflozin’s market base.

Linagliptin: A Preferred DPP-4 Inhibitor in Complex Cases

Linagliptin, marketed as Tradjenta by Boehringer Ingelheim, primarily addresses glycemic control with a favorable safety profile, particularly in patients with renal impairment due to its non-renally excreted pharmacokinetics. The drug gained market traction through its once-daily dosing and minimal hypoglycemia risk.

While DPP-4 inhibitors face stiff competition from newer agents and GLP-1 receptor agonists, linagliptin’s unique advantage remains its suitability in patients with advanced renal disease, where many competitors are contraindicated [3]. Its role within combination therapies further cements its market presence.

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Market Dynamics Shaping Trajectory

Regulatory Landscape

Regulatory agencies are increasingly favoring drugs with documented cardiovascular and renal benefits, benefiting empagliflozin. The EMA and FDA have approved multiple label extensions, creating new revenue streams. Conversely, DPP-4 inhibitors, including linagliptin, benefit from a mature regulatory profile, though newer agents are challenging their market share.

Competitive Landscape

The SGLT2 class, including canagliflozin and dapagliflozin, continues to grow, pressuring empagliflozin to maintain share through clinical differentiation and expanded indications. Similarly, DPP-4 inhibitors face competition from GLP-1 receptor agonists and SGLT2 inhibitors that offer superior cardiovascular and weight-loss benefits.

Pricing and Reimbursement

Pricing strategies are pivotal. Empagliflozin’s positioning as a cardio-renal protective agent allows premium pricing in developed markets, supported by insurance reimbursement due to demonstrated clinical value. Linagliptin’s cost-effectiveness, particularly in renal impairment, sustains its demand, especially in cost-sensitive healthcare systems.

Clinical Trial Pipeline and Innovation

Ongoing studies like DAPA-HF and EMPA-KIDNEY are poised to redefine empagliflozin’s market scope, potentially catalyzing multi-indication approvals. The evolution of combination therapies also influences market dynamics—fixed-dose combinations improve adherence and market penetration.

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Financial Trajectory and Revenue Outlook

Empagliflozin

Empagliflozin’s global sales reached approximately $4.6 billion in 2022, reflecting rapid growth fueled by cardiovascular and renal indications and expanding geographical presence [4]. The drug is projected to sustain a double-digit CAGR (~10-12%) through 2027, driven by:

• Expanded indications (e.g., heart failure, CKD)
• Increasing prevalence of comorbidities
• Strategic partnerships and biosimilar entry in certain markets

Linagliptin

Linagliptin’s annual revenues hover around $1.3 billion globally. While growth is slower (~3-5% CAGR), the drug remains a core component in combination regimens, especially in patients with renal impairment. Pricing pressures and competition from newer agents may temper growth; nonetheless, demand stability persists due to its specific niche.

Market Share and Competitive Positioning

Empagliflozin’s market share among SGLT2 inhibitors is approximately 30-35% in major markets, with expectations of expansion owing to label extensions and clinical trial success. Linagliptin maintains a stable share within the DPP-4 class (~15-20%), owing to its renal benefits and safety profile.

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Future Outlook

Empagliflozin is poised for ongoing growth, with potential revenues exceeding $7 billion by 2027. The emergence of cardio-renal indications, coupled with broader global adoption, reinforces its trajectory. Conversely, linagliptin faces a compression of margins but remains vital in specific cohorts, especially where cost and renal safety are paramount.

The upcoming clinical results and regulatory decisions will influence these trajectories, with a notable emphasis on the expanding role of SGLT2 inhibitors in heart failure and CKD management.

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Key Takeaways

• Empagliflozin’s proven cardiovascular and renal benefits underpin its strong market growth and expanding indications, promising a financial trajectory exceeding $7 billion globally within five years.
• Linagliptin maintains a niche focus, primarily benefiting patients with renal impairment, supporting steady revenue but facing competitive pressures.
• Regulatory approvals and clinical trial outcomes are critical drivers shaping future market shares and revenues.
• Pricing and reimbursement strategies, especially in emerging markets, will influence accessibility and sales volume.
• Strategic collaborations, combination therapies, and label extensions will be pivotal in sustaining growth for both agents.

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FAQs

1. What distinguishes empagliflozin’s market position from other SGLT2 inhibitors?
Empagliflozin’s leadership stems from its strong evidence base demonstrating cardiovascular and renal benefits, which have led to multiple label extensions and increased clinician adoption compared to peers like canagliflozin and dapagliflozin.

2. How does linagliptin’s non-renal excretion impact its market demand?
Its unique pharmacokinetics enable safe use in patients with advanced renal impairment, making it indispensable for this subgroup, thereby securing niche demand even as competition increases.

3. What upcoming clinical trials could influence empagliflozin’s commercial future?
DAPA-HF, EMPA-KIDNEY, and additional studies focused on heart failure and kidney disease are key, with positive results likely expanding indications and boosting revenues.

4. Are biosimilars a concern for empagliflozin and linagliptin?
While biosimilars mainly target biologics, cost-pressure from generics in key markets could eventually impact prices, especially in Europe and Asia, necessitating ongoing innovation and value demonstration.

5. How might healthcare policies influence the trajectory of these drugs?
Policies emphasizing value-based care and comprehensive management of comorbidities may favor agents with proven cardiovascular and renal benefits, bolstering empagliflozin’s market position more than traditional antihyperglycemics like linagliptin.

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References

[1] IQVIA. (2022). Global Diabetes Market Insights.
[2] Zinman, B., et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 373(22), 2117-2128.
[3] Groop, P. H., et al. (2019). The Role of Linagliptin in Renal Impairment. Diabetes Care, 42(8), 1504-1510.
[4] EvaluatePharma. (2023). Pharma Market Analysis: SGLT2 Inhibitors and DPP-4 Inhibitors.