empagliflozin; linagliptin - Profile

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.

There are three tentative approvals for this compound.

Summary for empagliflozin; linagliptin

International Patents:	521
US Patents:	22
Tradenames:	2
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for empagliflozin; linagliptin

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

Constraining patent/regulatory exclusivity:

7,579,449*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.

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.

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	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	9,173,859		Y		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	9,949,998
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	12,178,819		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	8,673,927*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	7,579,449*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	8,551,957*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	8,883,805*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	7,459,428
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	8,119,648
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	7,078,381
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	8,178,541
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	7,459,428

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
Australia	2014247092
Canada	2812519
Canada	2908635
Canada	3121761
Chile	2015002940
China	105377267
China	109893534

Supplementary Protection Certificates for empagliflozin; linagliptin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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...
2187879	PA2017014	Lithuania		PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO DERINYS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
2187879	C20170016 00337	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN/LINAGLIPTIIN;REG NO/DATE: EU/1/16/1146 15.11.2016
1730131	C01730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	200 5026-2014	Slovakia		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527

Last updated: February 3, 2026

pagliflozin and Linagliptin: Investment Scenario, Market Dynamics, and Financial Trajectory

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Summary

This report analyzes the investment landscape, market dynamics, and financial prospects for empagliflozin and linagliptin, two leading antidiabetic agents. Both drugs, approved for managing type 2 diabetes mellitus (T2DM), are key components of the global diabetes treatment market, which reflects rising prevalence, innovation, and competitive positioning. The report offers a comprehensive overview of revenue streams, regulatory and patent landscapes, competitive environment, and growth drivers, providing actionable insights for investors and stakeholders.

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What Are Empagliflozin and Linagliptin?

Drug Name	Therapeutic Class	Mechanism of Action	Approved Indications	Key Brands
Empagliflozin	SGLT2 inhibitor	Inhibits sodium-glucose co-transporter 2 in kidneys	T2DM, heart failure, CKD	Jardiance (Boehringer Ingelheim / Lilly)
Linagliptin	DPP-4 inhibitor	Inhibits dipeptidyl peptidase-4 enzyme	T2DM	Tradjenta (Boehringer Ingelheim)

Market Overview and Revenue Projections

Parameter	Empagliflozin (2022)	Linagliptin (2022)
Global Market Size	~$8.4 billion	~$2.1 billion
Expected CAGR (2022-2028)	~12-15%	~8-10%
Major Markets	US, Europe, Japan, China	US, Europe, Japan
Key Revenue Drivers	Growing T2DM prevalence, cardiovascular benefits	Rising T2DM cases, monotherapy and combination use

Note: Both drugs are expected to expand significantly, driven by their cardiovascular and renal protective effects.

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Market Dynamics: Drivers and Challenges

Key Market Drivers

1. Rising Global T2DM Prevalence

   • According to the International Diabetes Federation (IDF), approximately 537 million adults had diabetes in 2021; projected to reach 783 million by 2045.[1]
   • Increased prevalence enables larger patient populations for empagliflozin and linagliptin.

2. Emphasis on Cardiovascular and Renal Outcomes

   • Empagliflozin's approval for heart failure and CKD elevates its value proposition.
   • Regulatory endorsements (e.g., FDA, EMA) as cardioprotective agents bolster uptake.

3. Product Differentiation and Innovation

   • Empagliflozin's demonstrated reduction in cardiovascular mortality and hospitalization (EMPA-REG OUTCOME trial) enhances its market positioning.[2]
   • Linagliptin's favorable hepatic elimination profile suits patients with renal impairment.

4. Patent Expiry and Generic Entry

Drug	Patent Expiry	Generics Available	Impact
Empagliflozin	2028 (US)	No	Patent protection prolongs premium pricing
Linagliptin	2028 (US)	No	Patent expiry approaches, potential for generics

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Financial Trajectory and Investment Outlook

Empagliflozin	Linagliptin
Market Penetration	Higher in cardiovascular and renal markets	Strong position in monotherapy and combination therapy
Revenue Trends (2022-2028)	Expected compounded growth rates of 12-15%	8-10% CAGR, less aggressive but steady
Key Factors Influencing Revenue	New indications, label expansion, regional growth	Clinical trials, regulatory approvals, market penetration
Supply Chain and Manufacturing	Established manufacturing, supply chain resilience	Similar, with opportunities for cost optimization

Competitive Landscape

Leading Competitors	Market Share (2022)	Competitive Edge
Empagliflozin (Boehringer Ingelheim / Lilly)	~30% of SGLT2 inhibitor market	Cardiovascular benefits, brand recognition
Dapagliflozin (AstraZeneca)	~25%	Broader indication spectrum
Sitagliptin (Merck)	Leader among DPP-4s (~60% DPP-4 market)	Established efficacy, safety profile
Linagliptin (Boehringer Ingelheim)	~15-20%	Hepatic elimination advantageous for renal impairment

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Regulatory and Patent Landscape

Regulatory Milestones	Description
FDA Approvals	United States Food and Drug Administration approvals across various indications (2014-2018).
EMA Approvals	European Medicines Agency approvals, matching US indications.
Label Expansion Opportunities	Secondary indications include heart failure and CKD for empagliflozin; ongoing trials for linagliptin in combination therapies.

| Patent Status & Challenges | Potential patent expirations by 2028 may open generic markets, pressuring prices and margins. Patent challenges or extensions could alter timelines. |

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Investment Opportunities & Risks

Opportunities	Risks
Expansion into heart failure and CKD markets	Patent expiration and generic competition
Launch of new fixed-dose combinations (FDCs)	Regulatory delays or rejections
Growing adoption in emerging markets	Market saturation in mature markets
Accelerated adoption due to unmet needs in T2DM	Post-approval safety concerns or adverse events

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Comparison: Empagliflozin vs. Linagliptin

Aspect	Empagliflozin	Linagliptin
Therapeutic Class	SGLT2 inhibitor	DPP-4 inhibitor
Additional Indications	Heart failure, CKD	Primarily T2DM, with emerging combination therapies
Market Position	Leader in cardio-renal outcomes	Stable market presence, less aggressive growth
Patent Status	Expiring 2028 in key territories	Similar, with patent expiry expected in 2028

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Key Market Trends and Future Outlook

• Personalized Medicine: Increased focus on patient-specific treatment plans enhances drug value.
• Combination Therapies: Rise in fixed-dose combinations improves adherence and market share.
• Regulatory Tailwinds: Greater emphasis on cardiometabolic outcomes favors these agents.
• Market Penetration in Emerging Economies: Economic growth and rising diabetes prevalence provide expansion opportunities.

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Conclusion and Implications for Investors

Empagliflozin and linagliptin sit atop a rapidly expanding diabetes medication market, driven by increasing T2DM prevalence, regulatory endorsements, and the drugs’ cardiovascular and renal benefits. While empagliflozin offers higher growth prospects due to its broader therapeutic utility, linagliptin presents steady returns with lower market penetration risks. Patent expiries by 2028 pose a potential downside, necessitating strategic positioning ahead of generic entry. Stakeholders should monitor ongoing clinical trials, regulatory developments, and regional market expansions for optimized investment timing.

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Key Takeaways

• The global T2DM market is poised for robust growth, with a compounded CAGR exceeding 10% for leading drugs like empagliflozin and linagliptin.
• Empagliflozin’s cardiovascular and renal benefits give it a competitive advantage, positioning it as a premium therapeutic option.
• Patent expiries in 2028 will likely introduce generics, intensifying price competition; strategic innovation or portfolio diversification is essential.
• Emerging markets offer significant growth potential, driven by rising disease prevalence and access expansion.
• Increased adoption of combination therapies and fixed-dose formulations could enhance market penetration and revenue streams.

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FAQs

1. When do patents for empagliflozin and linagliptin typically expire, and how will this affect the market?
Patent protections are expected to expire around 2028 in major markets like the US and EU. This will likely lead to the entry of generics, reducing brand-name drug revenues and intensifying price competition.

2. How do the safety profiles of empagliflozin and linagliptin influence their market adoption?
Both drugs have favorable safety profiles; empagliflozin’s associated with risks like genital infections and rare ketoacidosis, while linagliptin’s primary concerns include mild gastrointestinal effects. Ongoing post-market surveillance maintains their strong therapeutic standing.

3. What role do regulatory agencies play in shaping the market trajectory?
Agencies like the FDA and EMA influence approval, label expansions, and indications. Recent approvals for heart failure and CKD markedly enhance these drugs' value and market applicability.

4. Are there significant regional differences impacting the sales of these drugs?
Yes. North America and Europe are mature markets with high penetration, whereas Asia-Pacific and Latin America present high-growth opportunities due to rising diabetes prevalence and expanding healthcare infrastructure.

5. How might future clinical trials influence the competitive landscape?
Successful trials for new indications or combination therapies can extend label indications, increase market share, and justify premium pricing, further boosting revenues.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] Zinman B, et al. "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes." New England Journal of Medicine, 2018.