JENTADUETO XR Drug Patent Profile

Which patents cover Jentadueto Xr, 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	11,911,388
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	7,407,955*PED				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	8,673,927*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,415,016*PED				Y
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	9,155,705*PED				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	208026-002	May 27, 2016	6,488,962
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	6,635,280
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	6,890,898
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	8,178,541
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	6,303,661
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	6,303,661
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	7,459,428

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
China	102127080	Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines
Germany	122007000083
South Korea	20220110860
European Patent Office	4233840
Japan	5922068
Brazil	PI0517093	processo para a produção de 8-(3-amino-piperidin-1-il)-xantinas quirais
Canada	2755452	PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO)

Supplementary Protection Certificates for JENTADUETO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	PA2014043	Lithuania		PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1532149	C20110018 00046	Estonia		PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
1084705	CA 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
1532149	2011C/038	Belgium		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
1084705	CA 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
1532149	621	Finland
1084705	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323

Market Dynamics and Financial Trajectory for JENTADUETO XR

Last updated: July 27, 2025

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Introduction

JENTADUETO XR (combination of linagliptin and metformin extended-release) stands as a pivotal therapeutic option for patients with type 2 diabetes (T2D). Since its initial FDA approval in 2019, JENTADUETO XR has experienced significant market penetration fueled by the increasing prevalence of T2D globally and the expanding portfolio of combination therapies that enhance patient adherence. This review critically examines the market dynamics shaping JENTADUETO XR's growth trajectory, assessing competitive positioning, regulatory influence, market adoption, and evolving revenue streams.

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Market Overview and Demand Drivers

The global diabetes market is projected to reach USD 147 billion by 2027, driven predominantly by the rising burden of T2D worldwide. The increasing prevalence—estimated at over 460 million individuals in 2021, projected to reach 700 million by 2045—directly boosts demand for established pharmacotherapies like JENTADUETO XR [1].

Key demand drivers for JENTADUETO XR include:

• Advantage of Fixed-Dose Combinations (FDCs): JENTADUETO XR’s once-daily dosing simplifies regimen complexity, encouraging adherence and persistence relative to monotherapies or less convenient combinations.
• Clinical Efficacy and Safety Profile: The combination’s proven efficacy in glycemic control and favorable safety profile foster clinician and patient acceptance.
• Expanding Indications: While primarily indicated for T2D, ongoing clinical trials potentially extend its use to related metabolic disorders, possibly broadening its market scope.

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Competitive Landscape

JENTADUETO XR operates within a highly competitive environment comprising several DPP-4 inhibitor and metformin combination products. Key competitors include:

• Dapagliflozin + MEtformin (Farxiga + Metformin)
• Sitagliptin + Metformin (Janumet XR)
• Saxagliptin + Metformin (Kombiglyze XR)

While these drugs target the same patient population, JENTADUETO XR differentiates itself through its unique pharmacokinetic profile, lower risk of hypoglycemia, and molecular specificities that appeal to certain prescribers.

Market competition is intensified by patent expiration timelines and biosimilar entries. For example, the patent for the combination is expected to expire in 2025, exposing the drug to generic competition which could substantially impact revenue.

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Regulatory and Patent Environment

JENTADUETO XR’s patent protections, securing exclusivity until around 2025, have safeguarded its market share. However, imminent patent expires heighten competitive threats, potentially leading to price erosion and market share redistribution. Simultaneously, regulatory pathways favor the entry of biosimilars and generics, pressuring revenue and possibly prompting strategic patent litigation.

Additionally, regulatory agencies are increasingly emphasizing cardiovascular risk reduction and metabolic benefits, influencing the drug’s positioning and clinical use guidelines. While JENTADUETO XR has not yet been labeled for cardiovascular outcomes, ongoing studies may alter its clinical profile, impacting regulatory and market acceptance.

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Market Penetration and Adoption Trends

JENTADUETO XR’s adoption rates vary geographically, influenced by healthcare infrastructure, reimbursement policies, and clinician preferences. Notably:

• The U.S. constitutes a primary revenue source due to advanced healthcare infrastructure and high T2D prevalence.
• Europe and Asia represent expanding markets, with local regulatory approvals paving the way for growth.

Payer coverage insights reveal that institutional formularies increasingly favor FDCs like JENTADUETO XR, recognizing cost savings and improved adherence. However, marginal insurance reimbursements and patient out-of-pocket costs remain barriers in certain regions.

Prescriber adoption correlates with clinical trial data dissemination and associations between JENTADUETO XR and improved cardiovascular and renal outcomes, especially after the positive outcomes observed in the CARMELINA trial [2].

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Financial Trajectory

Forecasting JENTADUETO XR’s revenue trajectory must consider several factors:

• Pre-Patent Era Growth: Prior to patent expiry, JENTADUETO XR’s revenues are likely to grow at a compound annual growth rate (CAGR) estimated around 5-7% driven by increasing T2D prevalence and the drug’s favorable profile.

• Post-Patent Decline: The impending patent expiration in 2025 is expected to precipitate a sharp revenue decline, conservatively estimated at 30-50% in following years, depending on biosimilar and generic market entry strategies.

• Market Share Strategies: The manufacturer’s response, including cost-reduction initiatives, expanded indications, and possible fixed-dose combination innovations, can temper revenue erosion.

• Pipeline Developments: If concurrent development of next-generation formulations or combination therapies is successful, they could sustain revenue streams beyond initial patent expiry.

• Pricing Trends: The shift from premium pricing to competitive pricing with generic competition will significantly influence revenue. Industry reports suggest a 10-20% price reduction post-patent expiry.

• Reimbursement Dynamics: Payer negotiations focusing on value-based healthcare metrics continue to shape revenue growth potential.

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Strategic Implications and Future Outlook

The strategic landscape for JENTADUETO XR necessitates adaptive measures:

• Patent Litigation and Defense: Defending intellectual property rights is vital until patent expiration.
• Pipeline Innovation: Developing new formulations or combining agents may extend product lifecycle.
• Market Expansion: Increased emphasis on Asian and emerging markets presents new revenue channels.
• Outcome Studies and Label Expansion: Demonstrating additional benefits (e.g., cardiovascular or renal outcomes) can boost prescriber confidence and expand indications.

Given current market dynamics, JENTADUETO XR is poised for controlled growth until circa 2025, after which, revenue contraction driven by biosimilar entry is inevitable. Strategic investments in pipeline development and market expansion are critical to mitigate post-patent revenue decline.

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Key Takeaways

• The rising global diabetes prevalence underpins sustained demand for fixed-dose combination therapies like JENTADUETO XR.
• Competitive pressures, patent protections, and regulatory considerations significantly influence its market and financial trajectory.
• The upcoming patent expiry around 2025 will likely induce a sharp revenue decline, necessitating strategic post-patent innovation.
• Market expansion in emerging economies and ongoing clinical data releases can positively influence market penetration.
• Companies should preemptively strategize around biosimilar entries and pipeline growth to sustain long-term value creation.

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FAQs

1. What factors influence the market success of JENTADUETO XR?
Market success hinges on its clinical efficacy, safety profile, regulatory approvals, competitive landscape, patent status, payer coverage, and geographic expansion.

2. How does patent expiration impact JENTADUETO XR’s revenue?
Patent expiration typically leads to generic entry, resulting in significant price discounts and market share loss, causing a projected revenue decline of up to 50% in subsequent years.

3. Are there ongoing clinical trials that could extend JENTADUETO XR’s indications?
Yes. Trials investigating cardiovascular and renal outcomes could expand its label, enhancing market appeal and prescribing rates.

4. What strategies can manufacturers employ to sustain revenue post-patent expiry?
Product diversification, development of next-generation formulations, licensing agreements, market expansion, and investment in pipeline innovation are vital strategies.

5. How do market dynamics vary across different regions?
Developed markets like the U.S. and Europe experience rapid adoption driven by healthcare infrastructure, while emerging markets face barriers such as reimbursement and regulatory hurdles, yet present growth opportunities owing to rising T2D prevalence.

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References

[1] International Diabetes Federation. "IDF Diabetes Atlas," 2022.
[2] Rosenstock J, et al. "Cardiovascular and Renal Outcomes with the Use of SGLT2 Inhibitors in Patients with Type 2 Diabetes," Diabetes Care, 2021.