JENTADUETO Drug Patent Profile

Which patents cover Jentadueto, and when can generic versions of Jentadueto launch?

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	9,173,859*PED				Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No	9,415,016*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	11,911,388
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	8,883,805*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	9,555,001*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	8,673,927*PED				Y

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	201281-002	Jan 30, 2012	6,890,898
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	8,119,648
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	8,178,541
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	7,078,381
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	6,303,661
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	6,303,661
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	8,178,541

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
Malaysia	174380
Eurasian Patent Organization	016752	ПРОМЕЖУТОЧНЫЕ СОЕДИНЕНИЯ ДЛЯ ПОЛУЧЕНИЯ ХИРАЛЬНЫХ 8-(3-АМИНОПИПЕРИДИН-1-ИЛ)КСАНТИНОВ (INTERMEDIATES FOR PRODUCING CHIRAL 8-(3-AMINOPIPERIDIN-1-YL)XANTHINES)
Poland	2015754
Japan	5588428
Singapore	157371	METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES
Croatia	P20140373
China	108635355

Supplementary Protection Certificates for JENTADUETO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	CA 2011 00030	Denmark
1084705	PA2014044	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
1532149	SPC/GB12/006	United Kingdom		PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830
1532149	2011/039	Ireland		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1532149	621	Finland
1532149	8/2012	Austria		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830

Market Dynamics and Financial Trajectory for JENTADUETO

Last updated: July 27, 2025

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Introduction

JENTADUETO, a prescription medication developed by AbbVie, combines two active ingredients—sitagliptin and metformin—targeting type 2 diabetes mellitus. Approved by the FDA in 2016, JENTADUETO has positioned itself within a highly competitive and rapidly evolving market. Its unique pharmacologic profile and positioning have catalyzed notable market penetration, while overarching market dynamics influence its long-term financial trajectory.

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Market Overview and Positioning

The global type 2 diabetes market represents a multibillion-dollar sector, expected to grow at a compounded annual growth rate (CAGR) of approximately 7% over the next five years, propelled by increasing prevalence rates, aging populations, and lifestyle factors [1]. JENTADUETO operates within the DPP-4 inhibitor and biguanide classes, serving patients inadequately managed by monotherapy.

AbbVie's strategic positioning emphasizes the combination therapy's convenience, reducing pill burden, and improving adherence—a critical factor given the chronic nature of diabetes management. As of 2022, JENTADUETO captured a significant portion of the fixed-dose combination (FDC) drug market, with projections indicating sustained growth driven by approvals expansion and increased physician adoption.

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Market Dynamics

1. Competitive Landscape

JENTADUETO faces competition from other FDCs and monotherapies, including Merck's Januvia (sitagliptin alone), Takeda's Nesina (alogliptin), and newer agents like GLP-1 receptor agonists and SGLT2 inhibitors. The arrival of SGLT2 inhibitors and GLP-1 receptor agonists—such as Jardiance (empagliflozin) and Trulicity (dulaglutide)—has reshaped treatment paradigms, emphasizing cardiovascular and renal benefits.

Despite this, JENTADUETO's combination offers advantages, including reduced pill burden and improved compliance. Its approval for specific populations and analytical data maintaining efficacy and safety in real-world settings reinforce its relevance despite intense competition [2].

2. Regulatory Developments and Patent Landscape

Initially protected by patents valid until approximately 2023–2024, AbbVie's patent estate for JENTADUETO is under scrutiny or facing challenges. Patent expirations typically lead to generic entry, exerting downward pressure on prices and sales volumes. Seekers of exclusivity—such as formulation patents or supplemental indications—are crucial in prolonging market share. Recent regulatory approvals for expanded indications, including outcomes studies on cardiovascular safety, further support its positioning.

3. Pricing, Reimbursement, and Market Access

Pricing strategies for JENTADUETO align with market norms for combination oral hypoglycemics: premium pricing justified by convenience and clinical efficacy. Reimbursement depends on negotiated prices with health insurers and national healthcare systems, particularly in developed markets like the US, Europe, and Japan. The drug's cost-effectiveness has been favorably evaluated, supporting ongoing reimbursement policies.

4. Demographic and Epidemiologic Drivers

The global surge in diabetes prevalence—estimated at over 537 million adults worldwide—poises JENTADUETO for sustained demand [3]. Senior populations with comorbidities, especially cardiovascular disease, benefit from combination therapies with proven safety profiles. Growing awareness and physician familiarity further propel prescriptions.

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Financial Trajectory

1. Revenue Projections

In 2022, JENTADUETO generated estimated revenues of approximately $1.2 billion globally. Analysts anticipate a compound annual growth rate (CAGR) of 4–6% over the next five years, driven by expanding indications, geographic reach, and increasing treatment rates.

2. Impact of Patent Expiry and Generic Entry

Patent expirations around 2023–2024 threaten revenue stability, with projected generic entrants potentially reducing prices by 60–80%. To mitigate this, AbbVie has prioritized lifecycle management strategies:

• Developing next-generation formulations.
• Expanding indications to include additional patient populations.
• Combining JENTADUETO components with other agents for broader therapeutic applications.

3. Growth Opportunities

Emerging therapeutic combinations with SGLT2 inhibitors or GLP-1 receptor agonists are under exploration. Clinical trials evaluating JENTADUETO in cardiovascular and renal outcomes may establish new value propositions, expanding market share.

4. Cost and Investment Considerations

AbbVie’s R&D investments aim to sustain product innovation. Marketing expenses, especially in emerging markets, are anticipated to rise to support penetration. Nonetheless, the firm’s robust pipeline ensures continued revenue diversification.

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Market Risks and Challenges

• Competitive Pressure: Continuous innovation by rivals threatens JENTADUETO’s market share.
• Regulatory and Patent Risks: Delays or adverse rulings regarding patents could accelerate generic competition.
• Pricing Pressures: Payers increasingly demand price reductions, especially post-patent expiry.
• Clinical Efficacy and Safety: Emerging data on alternative therapies or new safety concerns could influence prescribing behaviors.

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Conclusion

JENTADUETO’s market dynamics are shaped by a combination of strategic positioning, competitive pressures, regulatory environment, and demographic trends. The product’s financial trajectory remains favorable in the short to medium term but faces headwinds from patent expiry and intensifying competition. AbbVie’s proactive lifecycle management and pipeline diversification are pivotal in sustaining its revenue streams. Long-term success hinges on continued innovation, expanding indications, and adapting to evolving treatment paradigms.

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Key Takeaways

• Market Growth: The global diabetes market offers substantial growth opportunities, with JENTADUETO positioned as a convenient, effective therapy.
• Competitive Edge: Its fixed-dose formulation maintains appeal amidst emerging drug classes offering cardio-renal benefits.
• Patent Life Cycle: Approaching patent expiry necessitates strategic maneuvers—pipeline development and indication expansion—to preserve revenue.
• Revenue Outlook: Expect moderate growth supplemented by lifecycle strategies; post-patent periods may see significant pricing declines.
• Risk Management: Continuous clinical evidence generation and market adaptation are essential to counter competitive and regulatory challenges.

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FAQs

1. What factors influence JENTADUETO’s market share in the global diabetes market?
Market share depends on physician preference, patient adherence benefits, patent protection, competitive therapies, and reimbursement policies. Its combination therapy offers a convenience advantage, positively influencing adoption.

2. How does patent expiration affect JENTADUETO’s financial outlook?
Patent expiry opens the market to generics, typically leading to substantial revenue declines. To counteract this, AbbVie invests in lifecycle management, seeking new indications and formulations.

3. What are the key competitors to JENTADUETO, and how do they impact its market?
Competitors include SGLT2 inhibitors and GLP-1 receptor agonists, which offer additional cardiovascular and renal benefits. They challenge JENTADUETO’s market share, especially in high-risk patient populations.

4. How does the evolving landscape of diabetes treatment influence JENTADUETO’s sales?
Emerging therapies focusing on cardio-renal outcomes may supplant traditional agents; however, JENTADUETO’s proven efficacy and convenience sustain its relevance.

5. What strategic steps can AbbVie take to optimize JENTADUETO’s long-term profitability?
Investing in new clinical trials, expanding indications, developing combination therapies, and securing patent protections are vital.

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Sources:

[1] Grand View Research, "Diabetes Drugs Market Size, Share & Trends Analysis Report," 2022.
[2] U.S. Food and Drug Administration, "JENTADUETO Approved for Type 2 Diabetes," 2016.
[3] International Diabetes Federation, “IDF Diabetes Atlas,” 2022.