Empagliflozin; linagliptin; metformin hydrochloride - Generic Drug Details

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

Empagliflozin; linagliptin; metformin hydrochloride is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for empagliflozin; linagliptin; metformin hydrochloride

International Patents:	506
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin; linagliptin; metformin hydrochloride
DailyMed Link:	empagliflozin; linagliptin; metformin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for empagliflozin; linagliptin; metformin hydrochloride

Dosage:

TABLET, EXTENDED RELEASE;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; metformin hydrochloride

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1
Medanta, The Medicity, India	N/A
Wuxi People's Hospital	N/A

See all empagliflozin; linagliptin; metformin hydrochloride clinical trials

Pharmacology for empagliflozin; linagliptin; metformin hydrochloride

Drug Class	Biguanide 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; metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIJARDY XR	Extended-release Tablets	empagliflozin; linagliptin; metformin hydrochloride	5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g	212614	1	2020-05-26

US Patents and Regulatory Information for empagliflozin; linagliptin; metformin hydrochloride

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	212614-003	Jan 27, 2020		RX	Yes	No					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No			Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No					Y

Expired US Patents for empagliflozin; linagliptin; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020

International Patents for empagliflozin; linagliptin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Slovenia	1888552
Portugal	2187879
Hong Kong	1134076

Supplementary Protection Certificates for empagliflozin; linagliptin; metformin hydrochloride

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

Market Dynamics and Financial Trajectory for EMPAGLIFLOZIN, LINAGLIPTIN, and METFORMIN HYDROCHLORIDE

Last updated: August 8, 2025

Introduction

The global pharmaceutical landscape for type 2 diabetes mellitus (T2DM) management is evolving rapidly, driven by the increasing prevalence of the disease, emerging therapeutic options, and shifting regulatory and payer dynamics. Empagliflozin, linagliptin, and metformin hydrochloride represent pivotal components of therapeutic regimes, each with unique market trajectories grounded in clinical efficacy, safety profiles, and commercialization strategies. This analysis examines the current market dynamics and forecasts the financial trajectory of these drugs.

Current Market Landscape

Market Overview

T2DM affects approximately 463 million adults worldwide, projected to exceed 700 million by 2045, with the rising incidence fueling demand for effective management options. The global antidiabetic drugs market was valued at approximately USD 54 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 7-8% through 2030 [1].

Key Therapeutic Classes and Competition

The portfolio for T2DM includes metformin (biguanide class), DPP-4 inhibitors (linagliptin), and SGLT2 inhibitors (empagliflozin). Each class has demonstrated significant clinical benefits—metformin as first-line therapy, DPP-4 inhibitors for glycemic control with minimal hypoglycemia risk, and SGLT2 inhibitors for additional cardiovascular and renal benefits.

Regulatory & Market Access Dynamics

Regulatory agencies such as the FDA and EMA continuously scrutinize safety profiles, especially cardiovascular and renal outcomes. Recent approvals and label expansions significantly influence market reach and patient adoption.

Premiums and Pricing Strategies

Despite pricing pressures, especially in payers and healthcare systems with cost containment policies, drugs offering additional benefits—such as cardiovascular protection—maintain premium positioning. Empagliflozin, in particular, benefits from its cardiovascular mortality reduction demonstrated in the EMPA-REG OUTCOME trial [2].

Product-Specific Market Dynamics

Empagliflozin

Market Position & Adoption

Introduced as a pioneering SGLT2 inhibitor in 2014 (marketed as Jardiance), empagliflozin is notable for demonstrating mortality benefits in high-risk cardiovascular patients. Its broad indication expansion—from glycemic control to heart failure and chronic kidney disease (CKD)—has significantly enhanced its market penetration.

Competitive Landscape

Empagliflozin faces competition from other SGLT2 inhibitors such as canagliflozin and dapagliflozin. Yet, its distinct cardiovascular data bolster its premium position.

Financial Trajectory

The drug is projected to command a CAGR of approximately 8-10% through 2030, driven by increased adoption in cardiology and nephrology indications. The global sales are estimated to reach USD 7-8 billion annually by 2027 [3].

Linagliptin

Market Position & Adoption

Launched in 2011, linagliptin is a DPP-4 inhibitor with a unique pharmacokinetic profile—primarily non-renal clearance—making it suitable for patients with renal impairment. Its once-daily dosing further boosts adherence.

Competitive Landscape

Competing DPP-4 inhibitors include sitagliptin and saxagliptin. Linagliptin’s renal safety profile gives it a strategic edge in patients with CKD, broadening its market scope.

Financial Trajectory

Anticipated to grow at a CAGR of approximately 4-6%, the sales outlook for linagliptin remains stable but moderate, projected to reach USD 1.2-1.5 billion globally by 2027 [4].

Metformin Hydrochloride

Market Position & Adoption

As the most prescribed antidiabetic agent globally, metformin remains the cornerstone of T2DM management. Its low cost, well-documented efficacy, and safety profile sustain its dominant market share.

Market Challenges

Despite its widespread use, patent expirations have led to increased generic competition, pressuring prices. Moreover, emerging data on potential lactic acidosis risks in certain populations influence prescribing patterns.

Financial Trajectory

While growth in innovative drug classes diminishes marginally, the total sales volume remains robust, with global sales exceeding USD 2 billion annually. The total market for metformin is largely driven by generic formulations with minimal margins but high volume.

Market Drivers and Constraints

Drivers

• Epidemiological Burden: Rising T2DM prevalence expands patient pools.
• Clinical Benefits: Demonstrated cardiovascular, renal, and weight loss benefits bolster acceptance.
• Regulatory Support: Expanded indications and label updates enhance market access.
• Combination Therapies: Increased use with other antidiabetics amplifies sales.

Constraints

• Pricing Pressures: Cost containment policies in mature markets limit revenue growth.
• Generic Competition: Especially for metformin, eroding margins.
• Safety Concerns: Emerging adverse event data influence clinician prescribing behaviors.
• Market Saturation: High penetration of existing therapies constrains growth potential.

Future Projections and Financial Trends

Empagliflozin

Expected to lead the SGLT2 inhibitor market, empagliflozin’s revenues are projected to grow robustly over the next decade, reaching USD 7-8 billion annually by 2027. Expansion into heart failure with reduced ejection fraction (HFrEF) and CKD indications in multiple regions will fuel this trajectory.

Linagliptin

With its distinctive renal safety profile, linagliptin will continue to see steady, moderate growth. Innovation in fixed-dose combinations and its positioning for special populations will sustain sales growth, projected to plateau around USD 1.5 billion by 2027.

Metformin Hydrochloride

The market for metformin remains largely commoditized. While innovation is limited, the volume sales sustain a high baseline volume. The revenue growth is expected to be modest but resilient, driven primarily by demand in emerging markets.

Conclusion

The market dynamics for empagliflozin, linagliptin, and metformin hydrochloride emphasize the ongoing evolution of T2DM management. Empagliflozin’s positioning as a cardiovascular and renal protective agent offers a significant growth advantage. Linagliptin's safety advantage in renal impairment sustains its relevance, while metformin's fundamental role maintains its predominant market position. The combined effect of clinical data, regulatory evolution, and payer strategies will shape the financial trajectories of these drugs through the coming decade.

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Key Takeaways

• Empagliflozin's integration into cardiovascular and renal indications positions it for rapid growth, projected to reach USD 8 billion globally by 2027.
• Linagliptin’s renal safety profile ensures stable demand, with projected sales around USD 1.5 billion in five years.
• The metformin market remains volume-driven, with modest revenue growth amid patent expirations and generic competition.
• The shift toward personalized medicine, combination therapies, and expanding indications will be central to maximizing revenues.
• Competitive pressures and regulatory landscapes demand continuous innovation and strategic positioning for sustained profitability.

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FAQs

1. What factors are most influencing empagliflozin's market growth?
   Empagliflozin's growth is primarily driven by its proven cardiovascular and renal benefits, expanded indications, and inclusion in treatment guidelines for HFrEF and CKD, coupled with increasing global T2DM prevalence.

2. How does linagliptin differentiate from other DPP-4 inhibitors?
   Its non-renal clearance mechanism makes linagliptin suitable for patients with renal impairment, offering safety advantages and expanding its clinical utility.

3. What impact does patent expiry have on the metformin market?
   Patent expirations have led to a surge in generic availability, drastically reducing prices but maintaining high sales volumes due to metformin’s essential role in T2DM management.

4. Are there new formulations or combinations expected in these markets?
   Yes, fixed-dose combinations (FDCs) integrating empagliflozin or linagliptin with other antidiabetics are increasingly marketed to improve adherence and clinical outcomes.

5. What are the primary challenges facing these drugs' market expansion?
   Key challenges include pricing pressures, safety concerns, regulatory restrictions, and market saturation, especially for mature, generic drugs like metformin.

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References

[1] Research and Markets. "Global Diabetes Drugs Market," 2022.

[2] Zinman B, et al. "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes." New England Journal of Medicine, 2015.

[3] Evaluate Pharma. "SGLT2 Inhibitors Market Forecast," 2023.

[4] IQVIA. "DPP-4 Inhibitors Global Sales Data," 2022.