TRADJENTA Drug Patent Profile

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

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

This drug has four hundred and eighty-six patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tradjenta

A generic version of TRADJENTA was approved as linagliptin by SUNSHINE on August 31^st, 2021.

Summary for TRADJENTA

International Patents:	486
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	10
Drug Prices:	Drug price information for TRADJENTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRADJENTA
What excipients (inactive ingredients) are in TRADJENTA?	TRADJENTA excipients list
DailyMed Link:	TRADJENTA at DailyMed

See drug prices for TRADJENTA

See drug sales revenues for TRADJENTA

Recent Clinical Trials for TRADJENTA

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

Sponsor	Phase
EMS	Phase 3
University of Miami	Phase 4
Northwell Health	Phase 4

See all TRADJENTA clinical trials

Pharmacology for TRADJENTA

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

Paragraph IV (Patent) Challenges for TRADJENTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRADJENTA	Tablets	linagliptin	5 mg	201280	11	2015-05-04

US Patents and Regulatory Information for TRADJENTA

TRADJENTA is protected by eleven 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	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y

Expired US Patents for TRADJENTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011

EU/EMA Drug Approvals for TRADJENTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Trajenta	linagliptin	EMEA/H/C/002110Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.	Authorised	no	no	no	2011-08-23

International Patents for TRADJENTA

When does loss-of-exclusivity occur for TRADJENTA?

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

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Germany

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

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 TRADJENTA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20140048345
Mexico	PA05001684	8-[3-AMINO-PIPERIDIN-1-IL]-XANTINAS, LA PREPARACION DEL MISMO Y SU USO COMO COMPOSICIONES FARMACEUTICAS. (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS.)
Mexico	2007005404	PROCEDIMIENTO PARA PREPARAR 8-(3-AMINO-PIPERIDIN-1-IL)-XANTINAS QUIRALES. (METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES.)
Poland	216134
New Zealand	590787	DPP-4 inhibitors for treating diabetes in patients showing contraindication against metformin therapy

Supplementary Protection Certificates for TRADJENTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C01084705/01	Switzerland		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
0896538	CA 2007 00061	Denmark
0896538	300308	Netherlands		300308, 20170424, EXPIRES: 20220423
2187879	122017000024	Germany		PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRADJENTA

Last updated: September 30, 2025

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Introduction

TRADJENTA (linagliptin) stands as a pivotal oral antihyperglycemic agent developed by Boehringer Ingelheim and jointly marketed with Eli Lilly and Company. Approved by the U.S. Food and Drug Administration (FDA) in 2011, TRADJENTA is classified as a dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily in managing type 2 diabetes mellitus (T2DM). Its unique pharmacokinetics, competitive positioning, and evolving market landscape significantly influence its financial trajectory and overall market dynamics.

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Market Overview and Therapeutic Position

Global Diabetes Market:
The global diabetes treatment market valued at approximately USD 59.7 billion in 2022 is projected to reach USD 107.4 billion by 2030, reflecting a compound annual growth rate (CAGR) of over 7% (source: Fortune Business Insights). The expanding prevalence of T2DM, driven by lifestyle factors, obesity, and aging populations, underpins rising demand for antidiabetic medications such as TRADJENTA.

Market Position of TRADJENTA:
TRADJENTA holds a significant share within the DPP-4 inhibitor class, which includes drugs like Januvia (sitagliptin), Onglyza (saxagliptin), and Nesina (alogliptin). Its distinct advantages—once-daily dosing, minimal drug-drug interactions, and a low risk of hypoglycemia—have facilitated its uptake among prescribers and patients. Notably, linagliptin’s non-renal clearance offers superior safety for patients with renal impairment, further broadening its clinical applicability (source: FDA prescribing information).

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Market Dynamics Influencing TRADJENTA

1. Competitive Landscape and Market Share

The DPP-4 inhibitor segment is intensely competitive. Januvia, introduced earlier, commands approximately 60% of market share among DPP-4 inhibitors globally, with TRADJENTA capturing an estimated 10-15% (source: IQVIA, 2022). The differentiation strategies of Boehringer Ingelheim—such as emphasizing the renal safety profile—have been crucial to expanding its market penetration.

Emerging Competition:
The advent of SGLT2 inhibitors (e.g., Jardiance, Invokana) and GLP-1 receptor agonists (e.g., Ozempic, Trulicity) has shifted some market share away from DPP-4 inhibitors, especially among patients requiring weight loss and cardiovascular benefits. However, for patients with renal complications, TRADJENTA retains competitive edge due to its pharmacokinetic profile.

2. Regulatory and Provider Acceptance

Regulatory endorsements, such as guidelines from the American Diabetes Association (ADA), recognize DPP-4 inhibitors as effective second-line agents. The absence of significant cardiovascular or pancreatitis safety concerns supports broader adoption.

Additionally, real-world evidence showcasing safety in diabetic patients with comorbid renal disease has solidified TRADJENTA’s position, aligning with clinician preferences for tailored, patient-centric therapies.

3. Pricing and Reimbursement Factors

Pricing strategies critically influence market dynamics. As patent exclusivity persists, Boehringer Ingelheim maintains premium pricing; however, impending patent cliffs, especially in key markets like the U.S. and Europe, threaten revenue stability. Reimbursement policies, impacted by payer negotiations, also dictate access levels, shaping sales trajectories.

4. Product Lifecycle and Innovation

Strategic initiatives, including combination formulations with other antihyperglycemics (e.g., Jentadueto—a linagliptin and metformin combination), are expanding market options. Such innovations are crucial for sustaining long-term revenues amid commoditization pressures and patent expirations.

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Financial Trajectory and Revenue Outlook

Historical Performance:
Since its launch, TRADJENTA has demonstrated robust sales growth, with 2022 sales exceeding USD 1.2 billion globally (source: Boehringer Ingelheim annual report). The drug’s revenue growth reflects increasing adoption, especially in emerging markets such as China, Latin America, and Southeast Asia.

Forecasting Trends:
Projections indicate compounded annual growth of approximately 3-5% over the next five years. Several factors contribute to this forecast:

• Market Expansion: Growing global diabetic population, especially among aging and obese individuals.
• Regulatory Approvals: Expanded indications, such as delisting in certain territories for additional comorbidities.
• Pipeline Developments: Pending formulations, such as fixed-dose combinations, are expected to boost sales.

Risks and Challenges:
Patent expirations in major territories within the next 2-4 years introduce revenue pressures. Additionally, the competitive shift towards agents offering cardiovascular and weight reduction benefits could displace DPP-4 inhibitors in certain segments.

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Market Penetration Strategies and Future Outlook

To sustain financial growth, Boehringer Ingelheim leverages multiple avenues:

• Global Expansion: Entry into emerging markets with high diabetes prevalence.
• Brand Differentiation: Emphasizing safety profile, especially for patients with renal impairment.
• Combination Therapy: Developing and marketing fixed-dose combinations to improve adherence.
• Clinical Evidence Generation: Supporting the safety and efficacy profile through ongoing trials, thus reinforcing prescriber confidence.

Market trajectories suggest that while TRADJENTA will continue to grow, its market share might plateau or slightly decline post-patent expiry unless mitigated through lifecycle management strategies.

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Key Takeaways

• Robust Growth Drivers: The expanding diabetic population coupled with the drug’s unique safety profile secures TRADJENTA’s market presence.
• Competitive Challenges: The rise of cardio-renal protective agents and oral combination therapies will test its market share.
• Patent and Pricing Pressures: Approaching patent cliffs in key territories necessitate innovation and lifecycle strategies to preserve revenue.
• Market Expansion: Emerging markets represent fertile ground for growth, driven by increasing healthcare infrastructure and diabetes awareness.
• Strategic Innovation: Fixed-dose combinations and expanded indications are critical to extending the drug’s financial viability.

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FAQs

1. What are the primary advantages of TRADJENTA over other DPP-4 inhibitors?
TRADJENTA’s exclusive renal-free clearance reduces contraindications in patients with kidney impairment, providing a safety advantage over competitors like sitagliptin or saxagliptin.

2. How will patent expiration impact TRADJENTA’s sales?
Patent expiry typically results in generic competition, which can significantly reduce prices and market share. Boehringer Ingelheim’s lifecycle strategies, including formulations and combinations, aim to mitigate this impact.

3. Are there any ongoing clinical trials that could influence TRADJENTA’s market?
Yes. Clinical trials investigating cardiovascular and renal outcomes could bolster advocacy for TRADJENTA or similar agents if outcomes are favorable, further solidifying its clinical standing.

4. How significant are emerging competitors like SGLT2 inhibitors for TRADJENTA?
SGLT2 inhibitors offer cardiovascular and weight-loss benefits, attracting certain patient cohorts. While they pose competition, TRADJENTA remains relevant for patients prioritizing safety and renal considerations.

5. What strategic measures could Boehringer Ingelheim adopt to prolong TRADJENTA’s market relevance?
Developing fixed-dose combinations, expanding indications, and entering new geographical markets will be vital. Additionally, investing in real-world evidence to strengthen prescriber confidence remains critical.

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References

1. Fortune Business Insights. Diabetes Treatment Market Size, Share & Industry Analysis, 2023.
2. FDA Prescribing Information for TRADJENTA (linagliptin).
3. IQVIA. DPP-4 Inhibitors Market Share Report, 2022.
4. Boehringer Ingelheim Annual Report, 2022.
5. American Diabetes Association Guidelines, 2022.

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In conclusion, TRADJENTA’s market dynamics are shaped by a confluence of clinical advantages, competitive forces, regulatory landscapes, and strategic innovation. Its financial trajectory remains positive but requires proactive lifecycle management to navigate patent expirations and evolving market preferences.