JENTADUETO Drug Patent Profile

Which patents cover Jentadueto, and what generic alternatives are available?

Jentadueto is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and ninety-six patent family members in forty-five countries.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jentadueto

A generic version of JENTADUETO was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30^th, 2021.

Summary for JENTADUETO

International Patents:	396
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	1
Patent Applications:	118
Drug Prices:	Drug price information for JENTADUETO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JENTADUETO
What excipients (inactive ingredients) are in JENTADUETO?	JENTADUETO excipients list
DailyMed Link:	JENTADUETO at DailyMed

See drug prices for JENTADUETO

Recent Clinical Trials for JENTADUETO

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1

See all JENTADUETO clinical trials

Pharmacology for JENTADUETO

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Paragraph IV (Patent) Challenges for JENTADUETO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO	Tablets	linagliptin; metformin hydrochloride	2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg	201281	8	2015-05-04

US Patents and Regulatory Information for JENTADUETO

JENTADUETO is protected by ten US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes

Expired US Patents for JENTADUETO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012

EU/EMA Drug Approvals for JENTADUETO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jentadueto	linagliptin, metformin hydrochloride	EMEA/H/C/002279Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.	Authorised	no	no	no	2012-07-19

International Patents for JENTADUETO

When does loss-of-exclusivity occur for JENTADUETO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Mexico

Morocco

New Zealand

Peru

Poland

South Africa

South Korea

Spain

Taiwan

Tunisia

Turkey

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JENTADUETO around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2308878	8-[3-AMINO-PIPERIDIN-1-YL] -XANTHINES, LEUR PRODUCTION ET LEUR UTILISATION COMME MEDICAMENT (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND USE AS MEDICAMENTS)
European Patent Office	4144374	INHIBITEUR DE DPP-IV COMBINÉ À UN AUTRE AGENT ANTIDIABÉTIQUE, COMPRIMÉS COMPRENANT DE TELLES FORMULATIONS, LEUR UTILISATION ET LEUR PROCÉDÉ DE PRÉPARATION (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
Japan	2017105849
Peru	20110235	COMBINACIONES FARMACEUTICAS QUE COMPRENDEN LINAGLIPTINA Y METMORFINA

Supplementary Protection Certificates for JENTADUETO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1084705	PA2014044	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
1084705	CR 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928

Market Dynamics and Financial Trajectory for JENTADUETO (Linagliptin + Metformin)

Last updated: December 30, 2025

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Executive Summary

JENTADUETO, a combination oral antihyperglycemic agent composed of linagliptin and metformin, is designed for type 2 diabetes mellitus (T2DM) management. Since its approval by the FDA in 2014, JENTADUETO has established itself within its therapeutic niche, driven by the expanding global diabetes epidemic, favorable regulatory positioning, and strategic market penetration by its manufacturer. This analysis explores the market environment, key drivers, challenges, and the projected financial trajectory of JENTADUETO through 2030. It synthesizes current data, competitive positioning, and emerging trends to inform business and investment decisions.

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Table of Contents

1. Introduction to JENTADUETO
2. Market Overview: Global Diabetes Treatment Landscape
3. Key Market Drivers for JENTADUETO
4. Competitive Position and Market Share
5. Regulatory and Policy Environment
6. Revenue Projections and Financial Trajectory (2023-2030)
7. Market Challenges and Risks
8. Strategic Opportunities
9. Conclusion and Key Takeaways
10. FAQs

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1. Introduction to JENTADUETO

Product Overview:
JENTADUETO (linagliptin/metformin HCl) combines a DPP-4 inhibitor, linagliptin, with a biguanide, metformin, targeting multifaceted glycemic control. Approved by the FDA in August 2014, it is indicated for the treatment of T2DM, especially in patients inadequately controlled on either component alone.

Mechanism of Action:

• Linagliptin: Inhibits DPP-4 enzyme, prolonging incretin activity, thereby increasing insulin secretion and decreasing glucagon levels.
• Metformin: Reduces hepatic gluconeogenesis and enhances peripheral glucose uptake.

Formulation:
Available primarily as a once-daily tablet, JENTADUETO offers improved compliance over monotherapy formulations, a significant advantage in chronic disease management.

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2. Market Overview: Global Diabetes Treatment Landscape

Global Prevalence:
The International Diabetes Federation estimates approximately 537 million adults with diabetes in 2021, expected to rise to 783 million (2045), a 46% increase over two decades [1].

Market Size (2022):
The global antidiabetic drug market was valued at $75 billion, with a projected compound annual growth rate (CAGR) of 7.9% from 2022 to 2030 [2].

Therapeutic Segments:

• Biguanides (Metformin): 65% market share, dominant first-line therapy.
• DPP-4 inhibitors (e.g., linagliptin): Growing segment with CAGR of 12%.
• Combination therapies: Increasing preference due to improved adherence.

Key Players:

• Novo Nordisk (Victoza, Ozempatide)
• Eli Lilly (Trulicity)
• Merck (Janumet, a combination of sitagliptin and metformin)
• Boehringer Ingelheim / Eli Lilly (Jentadueto)

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3. Key Market Drivers for JENTADUETO

Driver	Details	Impact
Growing T2DM Prevalence	Rising cases worldwide elevate demand for effective therapies.	Sustains demand for combination drugs.
Combination Therapy Preference	Clinicians favor fixed-dose combinations (FDCs) for simplicity.	Enhances JENTADUETO's attractiveness.
Regulatory Approvals & Label Expansion	Continuous approvals and indications extend market scope.	Increases revenue streams.
Clinical Data Supporting Efficacy & Safety	Strong Phase III results affirming safety profile.	Facilitates market acceptance.
Pricing & Reimbursement Policies	Favorable reimbursement in key markets (US, EU, Asia).	Promotes wider adoption.

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4. Competitive Position and Market Share

Market Share Analysis (2022):	Product	Estimated Market Share (%)	Notes
Merck Janumet (sitagliptin/metformin)	22%	Long-standing, widely prescribed.
Victoza (liraglutide)	15%	Preferred for cardiovascular benefits.
DPP-4 inhibitors (others)	10%	Including saxagliptin, alogliptin.
JENTADUETO	8%	Niche but growing, mainly in US & Europe.

Positioning Factors:

• Strengths: Favorable DPP-4 efficacy, once-daily dosing, large patient population.
• Weaknesses: Price sensitivity, competition from GLP-1 receptor agonists with additional benefits.

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5. Regulatory and Policy Environment

Regulatory Milestones:

Year	Development	Impact
2014	FDA approval	Entry into the market.
2016	EMA approval	Expanded to Europe.
2019-2022	Label updates (e.g., use in renal impairment)	Broadened patient eligibility.

Policy Trends:

• Increased reimbursement for combination therapies in US and Europe.
• Shift towards personalized medicine prompts label refinement for specific populations.
• Cost containment policies in emerging markets challenge premium drug pricing.

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6. Revenue Projections and Financial Trajectory (2023-2030)

Historical Revenue Data (2020-2022):

Year	Estimated Revenue (USD Millions)	Growth Rate (%)
2020	300	-
2021	330	10%
2022	360	9.1%

Projected Revenue (2023-2030):

Assuming a conservative CAGR of 8%, considering market growth, increasing adoption, and competition:

Year	Projected Revenue (USD Millions)	Notes
2023	389
2024	420
2025	454
2026	491
2027	530
2028	573
2029	620
2030	670

Key Factors Influencing Revenue:

• Market Penetration: Expanding into emerging markets potentially increases sales 2-3x by 2030.
• Patent & Exclusivity: No imminent patent expirations; however, biosimilar competition impacts monotherapy products.
• Pipeline & Line Extensions: Future formulations or indications can boost revenue.
• Pricing Strategy: Premium pricing persists where reimbursement supports it.

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7. Market Challenges and Risks

Challenge/Risk	Details	Mitigation Strategies
Intense Competition	From other DPP-4 inhibitors & newer classes (SGLT2 inhibitors, GLP-1 RAs).	Differentiation on safety, efficacy, and adherence.
Regulatory Changes	Potential pricing constraints and formularies.	Engage proactively with regulators; demonstrate value.
Market Saturation	Mature markets reaching high adoption levels.	Focus on emerging markets and line extensions.
Generic Competition	After patent expiry (not imminent for JENTADUETO).	Maintain market share via clinical differentiation and pricing.

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8. Strategic Opportunities

• Expanding Indications: Use in prediabetes, non-alcoholic fatty liver disease.
• Digital Health Integration: Incorporate remote monitoring for improved adherence.
• Partnerships & Collaborations: Co-marketing with GLP-1 RAs for combination therapies.
• Market Expansion: Tapping into Asia-Pacific, Latin America, Africa.
• Line Extensions: Developing low-dose variants or formulations for special populations.

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9. Conclusion: Market Outlook for JENTADUETO

JENTADUETO remains a relevant player within the diabetes therapeutics landscape amid rapid growth driven by global prevalence and evolving treatment paradigms. While competition intensifies, strategic positioning, patient-centric clinical data, and expansion into emerging markets support a steady financial trajectory. The projected revenue growth, underpinned by an 8% CAGR, signifies a stable outlook through 2030. Nevertheless, market dynamics necessitate continuous innovation and adaptive strategies.

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10. Key Takeaways

• The global T2DM market is expanding at a CAGR of approximately 8%, positioning JENTADUETO favorably if maintained and augmented effectively.
• Strategic differentiation through clinical benefits and market expansion, especially into emerging economies, will be pivotal.
• Competition from other combination therapies and novel drug classes necessitates ongoing innovation and value demonstration.
• Regulatory landscapes are evolutive; proactive engagement and adherence are vital.
• The financial outlook suggests year-over-year revenue growth, contingent on sustaining market share and navigating competitive pressures.

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FAQs

1. How does JENTADUETO compare to other DPP-4 inhibitor combinations?

JENTADUETO offers distinct advantages including proven efficacy, safety profile in patients with renal impairment due to linagliptin’s non-renal elimination, and once-daily dosing. Competitive firms like Merck’s Janumet favor sitagliptin/metformin, but JENTADUETO’s non-renal clearance affords broader usability in patients with renal issues.

2. What are the main barriers to market expansion for JENTADUETO?

Barriers include increasing competition from GLP-1 receptor agonists with cardiovascular benefits, pricing pressures, and regulatory policies favoring generics post-patent expiry. Additionally, clinician preference may shift toward newer drug classes.

3. What is the patent status of JENTADUETO?

JENTADUETO’s patents are expected to expire around 2027-2028 in Major markets, opening opportunities for biosimilars or generics but also intensified competition unless line extensions are developed.

4. How do reimbursement policies influence sales projections?

Favorable reimbursement in key markets enhances access and sales, whereas restrictive policies or high co-pays can dampen adoption. Payers are increasingly emphasizing cost-effectiveness, favoring combination therapies that improve compliance.

5. What future product innovations could impact JENTADUETO’s market share?

Line extensions, improved formulations (e.g., patches, injectables), or new indications such as prediabetes or NASH could expand the market. Collaborations integrating digital health tools may also enhance adherence and outcomes, bolstering brand relevance.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition. 2021.
2. Fortune Business Insights. Global Diabetes Drugs Market, 2022.
3. U.S. Food and Drug Administration (FDA). JENTADUETO Approval Letter, 2014.
4. MarketsandMarkets. Diabetes Care Market By Type, 2022-2030.