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-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Empagliflozin; linagliptin has five hundred and twenty-one patent family members in forty-five countries.

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

Summary for EMPAGLIFLOZIN; LINAGLIPTIN

International Patents:	521
US Patents:	22
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
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	212614-001	Jan 27, 2020		RX	Yes	No	11,833,166*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	8,883,805*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	8,883,805*PED				Y
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	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	10,258,637*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	9,173,859		Y		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	8,178,541
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	7,459,428
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,119,648
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	8,178,541
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
Denmark	2015754
New Zealand	609765	Uses of dpp-iv inhibitors
Peru	20060120	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS
Canada	2696558
European Patent Office	3939577
Uruguay	29190	PROCEDIMIENTO PARA PREPARAR 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS QUIRALES
Japan	2009535381

Supplementary Protection Certificates for EMPAGLIFLOZIN; LINAGLIPTIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	LUC00017	Luxembourg		PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
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	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131	C01730131/05	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
2187879	C20170016 00337	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN/LINAGLIPTIIN;REG NO/DATE: EU/1/16/1146 15.11.2016
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

EMPAGLIFLOZIN; LINAGLIPTIN Market Analysis and Financial Projection

Last updated: February 11, 2026

What Are the Market Dynamics for EMPAGLIFLOZIN and LINAGLIPTIN?

EMPAGLIFLOZIN and LINAGLIPTIN are diabetes management medications that have experienced significant market shifts from their introductions to current standings. Both are part of newer classes with distinct mechanisms: EMPAGLIFLOZIN as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, LINAGLIPTIN as a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Market Size and Growth Trends

The global diabetes drug market is valued over USD 60 billion in 2023, expected to reach USD 80.3 billion by 2028, with a compound annual growth rate (CAGR) of 5.7%. The segment for SGLT2 inhibitors is growing fastest, with a CAGR of 15.4%, driven by their expanded approval for heart failure and chronic kidney disease indications.

Recent market data positions EMPAGLIFLOZIN as one of the top-selling SGLT2 inhibitors. Johnson & Johnson, through its Janssen division, reports U.S. sales of EMPAGLIFLOZIN (brand: Jardiance) reaching USD 3.2 billion in 2022, a 22% year-over-year increase.

LINAGLIPTIN (brand: Trajenta/Trelagliptin) holds a smaller market share but remains relevant in the DPP-4 class. Global sales stood around USD 1.2 billion in 2022, reflecting modest growth pending new formulary and regional expansion.

Competitive Landscape and Market Share

• EMPAGLIFLOZIN dominates the SGLT2 inhibitors market, competing with Dapagliflozin (Farxiga/Farxiga), Canagliflozin (Invokana), and Ertugliflozin (Steglatro). Janssen’s early lead in cardiovascular benefits and label expansion has solidified its position.

• LINAGLIPTIN faces competitive pressure from other DPP-4 inhibitors like Sitagliptin (Januvia), Saxagliptin (Onglyza), and Vildagliptin. Its smaller market share limits its growth pace but maintains a stable position due to established efficacy and a favorable side-effect profile.

Regulatory and Clinical Influences

Regulatory approvals increasingly incorporate expanded indications. EMPAGLIFLOZIN has gained approval for heart failure with reduced ejection fraction (HFrEF) in multiple regions, further expanding market potential. LINAGLIPTIN benefits from consistent approval status in numerous countries with incremental indications.

Clinical trial data influence market dynamics significantly. EMPAGLIFLOZIN’s cardiovascular and renal benefits are well-documented through EMPA-REG OUTCOME and other studies, supporting its preferential positioning. LINAGLIPTIN’s profile remains centered on glycemic control, limiting its differentiation.

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What Is the Financial Trajectory of EMPAGLIFLOZIN?

Sales Performance and Revenue Growth

• 2022 Sales: USD 3.2 billion (Janssen)
• 2023 Forecast: USD 3.9 billion, representing 21.9% growth
• 2025 Target: Exceed USD 4.8 billion globally, assuming steady market penetration and expanded indications

Profitability and Cost Factors

• Gross margins for EMPAGLIFLOZIN products exceed 70%, reflecting high demand and patent protections.
• Costs associated with manufacturing remain stable, but marketing, promotion, and regional expansion expenses increase as Johnson & Johnson targets new markets.

Market Expansion and Pipeline Potential

• EMA and FDA approvals for heart failure, chronic kidney disease, and other indications are expected to sustain revenue growth.
• Combined with ongoing label expansions, sales are projected to grow at a CAGR of approximately 10% through 2028.

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What Is the Financial Outlook for LINAGLIPTIN?

Sales Performance and Revenue Trends

• 2022 Sales: USD 1.2 billion
• 2023 Forecast: USD 1.4 billion, a 16.7% increase as market expansion continues
• Long-term Outlook: Moderate growth, reaching USD 1.8 billion by 2028, assuming ongoing penetration in emerging markets

Profitability and Cost Dynamics

• Profit margins approximately 65%, supported by stable manufacturing costs and existing patent protections.
• Growth is limited compared to newer classes but benefits from established prescriber confidence.

Pipeline and Regional Development

• Limited pipeline activity compared to EMPAGLIFLOZIN; focus remains on incremental indication extensions.
• Regional expansion into Asia-Pacific and Latin America offers growth potential, but regulatory approvals remain a key hurdle.

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How Do Current Market Policies and Patent Protections Impact the Trajectories?

Patent protections extend into the late 2020s for both drugs, with EMPAGLIFLOZIN's core patents expiring around 2026-2028, after which generic versions could pressure pricing. LINAGLIPTIN’s patents expire around 2027, limiting future revenue growth if generics enter the market.

Regulatory policies favor innovative therapies with proven cardiovascular and renal benefits, particularly in the U.S. and Europe, rewarding investments in clinical trials. Countries with high diabetes prevalence, such as India and Brazil, seek cost-effective generics, affecting pricing strategies.

What Are the Key Risks and Opportunities?

Risks

• Patent expirations reducing pricing power.
• Regulatory delays impacting regional expansion.
• Competitive entries from next-generation therapies including GLP-1 receptor agonists.
• Safety concerns highlighted in post-marketing surveillance may limit use.

Opportunities

• Label expansions for EMPAGLIFLOZIN in heart failure and kidney disease.
• Increased uptake owing to cardiovascular outcome benefits.
• Ongoing clinical trials exploring combination therapies.
• Growing awareness of the importance of cardiovascular and renal protection in diabetics.

Key Takeaways

1. EMPAGLIFLOZIN's market dominance is driven by clinical evidence supporting cardiovascular and renal benefits, with sales projected to grow at a CAGR around 10% through 2028.
2. LINAGLIPTIN remains stable with modest growth, limited by regional market penetration and impending patent expiries.
3. Patent protections influence pricing and market share; generics could enter as early as 2026 for EMPAGLIFLOZIN.
4. Expanding indications and regulatory approvals for EMPAGLIFLOZIN are primary growth drivers.
5. Competition from emerging classes (GLP-1 receptor agonists, SGLT2 alternatives) presents both challenges and opportunities for market incumbents.

FAQs

1. Will EMPAGLIFLOZIN continue to lead in the SGLT2 inhibitor market?
Yes, due to its strong cardiovascular study backing and expanded indications, EMPAGLIFLOZIN maintains industry leadership, but competitor development and patent expiries pose risks.

2. How soon could generics impact LINAGLIPTIN’s sales?
Patents expire around 2027; generic versions could enter markets within 1-2 years post-expiry, potentially reducing prices and sales.

3. Are new indications a significant growth factor for EMPAGLIFLOZIN?
Yes, especially for heart failure and chronic kidney disease, where regulatory approvals promote increased prescribing.

4. What regional markets offer the most growth potential?
Asia-Pacific and Latin America are emerging markets with increasing diabetes prevalence, offering expansion opportunities despite price sensitivity.

5. What therapeutic trends could affect these drugs' future?
The shift toward combination therapies, the rise of GLP-1 receptor agonists, and evolving guidelines emphasizing cardiovascular benefits could alter their market positions.

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References

1. Statista. (2023). Diabetes Drugs Market Size.
2. Johnson & Johnson. (2022). Annual Report.
3. EvaluatePharma. (2022). Top-selling Diabetes Drugs.
4. FDA. (2023). Approvals and Label Extensions.
5. GlobalData. (2023). Diabetes Market Overview.