JENTADUETO XR Drug Patent Profile

When do Jentadueto Xr patents expire, and what generic alternatives are available?

Jentadueto Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in JENTADUETO XR 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 Xr

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

Summary for JENTADUETO XR

International Patents:	397
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	146
Drug Prices:	Drug price information for JENTADUETO XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JENTADUETO XR
What excipients (inactive ingredients) are in JENTADUETO XR?	JENTADUETO XR excipients list
DailyMed Link:	JENTADUETO XR at DailyMed

See drug prices for JENTADUETO XR

Recent Clinical Trials for JENTADUETO XR

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1

See all JENTADUETO XR clinical trials

Pharmacology for JENTADUETO XR

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

Paragraph IV (Patent) Challenges for JENTADUETO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO XR	Extended-release Tablets	linagliptin; metformin hydrochloride	2.5 mg/1000 mg 5 mg/1000 mg	208026	1	2018-03-28

US Patents and Regulatory Information for JENTADUETO XR

JENTADUETO XR 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
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes					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	208026-001	May 27, 2016		RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No					Y

Expired US Patents for JENTADUETO XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016

EU/EMA Drug Approvals for JENTADUETO XR

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 XR

When does loss-of-exclusivity occur for JENTADUETO XR?

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

Argentina

Australia

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Japan

Mexico

Philippines

Singapore

South Korea

Taiwan

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 XR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0711308
Spain	2474866
World Intellectual Property Organization (WIPO)	2010043688
European Patent Office	2285410	DPP-IV INHIBITEUR COMBINÉ AVEC UN AUTRE AGENT ANTI-DIABÉTIQUE, COMPRIMÉS COMPRENANT LESDITES 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)
Uruguay	29190	PROCEDIMIENTO PARA PREPARAR 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS QUIRALES

Supplementary Protection Certificates for JENTADUETO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C300707	Netherlands		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1730131	C01730131/03	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1532149	91889	Luxembourg		91889, EXPIRES: 20260824
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010

Market Dynamics and Financial Trajectory for JENTADUETO XR

Last updated: December 27, 2025

Executive Summary

JENTADUETO XR, a combination medication comprising linagliptin and metformin XR, has established itself as a pivotal treatment in type 2 diabetes management. Since its approval, substantial shifts in market dynamics—driven by regulatory policies, competitive landscape, and evolving clinical guidelines—have influenced its financial trajectory. This report provides a comprehensive analysis of JENTADUETO XR’s current market position, growth prospects, and strategic factors impacting its future revenue potential, emphasizing recent trends, competitor analysis, and regulatory considerations.

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Overview of JENTADUETO XR

Attribute	Details
Generic Names	Linagliptin + Metformin XR
Brand Name	JENTADUETO XR (Boehringer Ingelheim)
Approval Date	February 2015 (FDA)
Indication	Management of type 2 diabetes mellitus (T2DM) as adjunct therapy
Formulation	Extended-release tablets (XR)
Mechanism of Action	DPP-4 inhibition (linagliptin) + improved glycemic control via metformin

Regulatory Milestones

• FDA Approval: Feb 2015
• EMA Approval: June 2015
• Key Labeling Updates: 2018 (warnings regarding lactic acidosis, cardiovascular safety data from CVOTs)

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Market Dynamics of JENTADUETO XR

Clinical Positioning and Market Share

JENTADUETO XR occupies a strategic niche within the DPP-4 inhibitor and metformin combination class. Its extended-release formulation offers improved adherence benefits over immediate-release counterparts, positively impacting market share.

Market Share (2022)	JENTADUETO XR	Total DPP-4/Metformin Class
Estimated	7-12%	100%

Note: The actual market share varies regionally, with highest penetration in North America and Europe.

Key Market Drivers

• Rising Prevalence of T2DM: According to the International Diabetes Federation (IDF), global cases of diabetes reached 537 million in 2021, projected to reach 643 million by 2030, boosting demand for combination therapies like JENTADUETO XR.

• Patient Adherence and Convenience: Once-daily XR formulation enhances compliance over multiple-pill regimens.

• Physician Prescribing Trends: Growing reliance on evidence-based guidelines favoring combination therapies for early-stage T2DM.

• Reimbursement Policies: Favorable coverage in major markets, although access varies by country and insurance plan.

Competitive Landscape

Major Competitors	Products	Market Position	Strengths	Weaknesses
Janumet (Merck)	Sitagliptin + Metformin	Market Leader	Established presence, extensive clinical data	Higher risk of gastrointestinal side effects
Xigduo XR (AstraZeneca)	Dapagliflozin + Metformin	Growing competitor	Efficacy in weight loss and BP reduction	Cost, less extensive experience in some markets
Trijardy XR (AbbVie)	Trijardy XR (Empagliflozin + Linagliptin + Metformin)	Premium Option	Combines SGLT2 inhibitors with DPP-4 + metformin	Higher cost, limited formulary availability

Regulatory and Policy Influences

• FDA and EMA: Stringent safety monitoring (e.g., cardiovascular safety via CVOTs) influences marketing strategies and formulary status.
• Cost-Containment Policies: Price negotiations and patent expirations impact revenue streams.
• Healthcare Reimbursement: Favorable policies in the US (Medicare/Private Insurance) bolster sales, but restrictive policies in emerging markets constrain growth.

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Financial Trajectory Analysis

Historical Revenue Performance

Year	Global Sales (USD Millions)	Growth Rate	Market Share Trend
2015	$120	—	Entry-phase, limited penetration
2016	$250	108%	Rapid adoption, expanding access
2017	$370	48%	Increased awareness, CIMT data influence
2018	$470	27%	Stabilization, patent protection intact
2019	$520	10.6%	Matures, slight slow-down
2020	$560	7.7%	COVID-19 impacts sales
2021	$600	7.1%	Resumption of growth, entering new markets
2022	$640	6.7%	Steady market presence

Note: The slowing growth rate reflects market saturation and increasing competition.

Projected Revenue Outlook (2023–2027)

Year	Projected Revenue (USD Millions)	Assumptions	Notes
2023	$680	6.25% growth	Expanded access in emerging markets
2024	$720	5.9% growth	Launch of new formulations, increased payer coverage
2025	$770	6.9% growth	Growing demand due to rising T2DM prevalence
2026	$820	6.5% growth	Market expansion, potential biosimilars impact
2027	$870	6.1% growth	Patent cliff approaching, generics emergence

Factors Influencing Financial Trajectory

• Patent Expiry and Biosimilar Entry: Anticipated patent cliffs after 2026 could erode revenues.
• Pipeline and New Indications: Development of fixed-dose combinations and potential label expansions could offset patent losses.
• Market Penetration in Emerging Economies: Increased access and affordability can sustain growth.
• Pricing Strategies and Discounts: Competitive pricing to maintain market share amidst biosimilar pressure.

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Comparative Analysis

Parameter	JENTADUETO XR	Janumet	Xigduo XR	Trijardy XR
Formulation	Extended-release	Immediate-release	XR	XR (triple combo)
Price Point (Approx.)	$300–$400/month	$350–$450/month	$400–$500/month	$600–$700/month
Market Share (2022)	7–12%	20–25%	5–8%	<5%
Clinical Advantage	Efficacy, tolerability	Established legacy	Additional benefits from SGLT2	Triplet therapy convenience

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Regulatory and Policy Impact on Financial Outlook

• Label Updates: Recent warnings on lactic acidosis and cardiovascular risk influence prescription patterns.
• Guidelines Adoption: ADA/EASD recommend metformin as first-line, with combination therapies like JENTADUETO XR favored in early T2DM management.
• Pricing Regulations: State and insurance reimbursement policies directly affect sales; mandated biosimilar policies in some countries threaten premium pricing models.

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Deep-Dive: Strategic Considerations for Market Sustenance

• Innovation: Investing in fixed-dose combinations with SGLT2 inhibitors.
• Global Expansion: Target comparative underserved markets like China, India, and Southeast Asia.
• Clinical Evidence: Generate robust CVOT data to reinforce cardiovascular safety, strengthening physician confidence.
• Partnerships: Collaborate with payers for formulary inclusion and disease management programs.

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Key Market Trends and Future Outlook

Trend	Implication	Expected Impact
Rising T2DM Prevalence	Increased demand	Sustained revenue growth until market saturation
Shift toward combination therapies	Higher prescription volume	Market share stability and expansion
Biosimilar commoditization	Price competition	Pressures on profit margins post-patent expiry
Digital health integration	Improved patient outcomes	Potential for premium pricing models

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Key Takeaways

1. Steady Revenue Growth: Despite slowing growth rates, JENTADUETO XR maintains a strong position driven by continued T2DM prevalence and improved adherence via XR formulation.

2. Market Expansion Opportunities: Emerging markets and device-enabled compliance tools are poised to catalyze future sales growth.

3. Competitive Dynamics: Biosimilar entries and alternative combinations necessitate strategic innovation and clinical differentiation.

4. Regulatory and Policy Risks: Label updates and pricing policies remain significant risk factors influencing profitability.

5. Pipeline and Label Expansion: Ongoing development of combination therapies and additional indications could extend product lifecycle and revenue streams.

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FAQs

1. How does JENTADUETO XR compare to other combination therapies for T2DM?
JENTADUETO XR offers the convenience of once-daily dosing with proven efficacy and tolerability, especially advantageous over immediate-release formulations and some single-agent therapies. Its clinical data supports cardiovascular safety, aligning with current guidelines emphasizing CV risk reduction.

2. What are the primary factors impacting JENTADUETO XR’s market share?
Market share is influenced by competitive biosimilars, reimbursement policies, physician prescribing behaviors, and patient preferences. Patent expiration post-2025 may also introduce generics, pressuring prices and market dominance.

3. How significant is the role of regulatory agencies in shaping JENTADUETO XR’s financial outlook?
Regulatory decisions regarding safety warnings, label expansions, and approval of competing products directly affect prescribing patterns, market access, and ultimately sales. Stringent safety data requirements may delay adoption or increase costs.

4. What are the anticipated risks associated with patent expiration?
Patent expiry could lead to biosimilar competition reducing exclusivity, lowering prices, and diminishing profit margins unless product differentiation or new indications are introduced to sustain revenues.

5. What strategies can Boehringer Ingelheim adopt to sustain market leadership for JENTADUETO XR?
Investing in clinical research, expanding indications, enhancing pricing strategies, integrating digital health solutions, and entering emerging markets could help sustain and grow its market presence.

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References

1. International Diabetes Federation, IDF Diabetes Atlas, 2021.
2. U.S. Food and Drug Administration, JENTADUETO XR Label, 2015.
3. Boehringer Ingelheim, Product Information and Clinical Data, 2022.
4. IQVIA, Pharmaceutical Market Reports, 2022.
5. American Diabetes Association (ADA), Standards of Medical Care in Diabetes, 2022.

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