TRADJENTA Drug Patent Profile

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

Tradjenta 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 eighty-one patent family members in forty-one 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:	381
US Patents:	10
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 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	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes	11,911,388
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes	10,034,877*PED				Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes	8,883,805*PED				Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes

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	7,078,381
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	6,303,661
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	8,178,541
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	7,459,428

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:

Canada

China

Denmark

Eurasian Patent Organization

Japan

Singapore

Slovenia

Taiwan

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
Tunisia	2011000060	TREATMENT FOR DIABETES IN PATIENTS INAPPROPRIATE FOR METFORMIN THERAPY
Norway	20031574
Slovenia	2283819
South Korea	100950722

Supplementary Protection Certificates for TRADJENTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	SPC/GB14/085	United Kingdom		PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
2187879	17C1016	France		PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
0896538	08C0008	France		PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926

Market Dynamics and Financial Trajectory for TRADJENTA

Last updated: February 27, 2026

What is TRADJENTA and what is its current market position?

TRADJENTA (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor approved by the FDA in 2017 for type 2 diabetes management. Manufactured by Boehringer Ingelheim, it is marketed as a once-daily oral medication. As of 2022, it held a notable position within the DPP-4 inhibitor segment, with a focus on adult populations with inadequate glycemic control.

The drug’s primary competitors include Januvia (sitagliptin) by Merck and Onglyza (saxagliptin) by Bristol-Myers Squibb. TRADJENTA's differentiated profile includes a renal-friendly dosing profile, which reduces the need for dose adjustments in patients with renal impairment.

How does the current market size look?

The global type 2 diabetes drug market was valued at approximately USD 77.2 billion in 2022. The segment for DPP-4 inhibitors accounted for around 20% (USD 15.4 billion). TRADJENTA's market share in DPP-4 inhibitors was estimated at 10% in 2022, translating to USD 1.5 billion in revenue.

Parameter	2022 Data
Global diabetes market	USD 77.2 billion
DPP-4 inhibitor segment	USD 15.4 billion
TRADJENTA market share	10% of segment
TRADJENTA revenue (approx)	USD 1.5 billion

What are the key drivers influencing TRADJENTA's financial growth?

Increasing prevalence of type 2 diabetes

Global diabetes prevalence stood at 537 million in 2021, projected to reach 643 million by 2030. Rising disease incidence drives demand for effective medications.

Favorable dosing profile and safety

TRADJENTA’s renal safety profile diminishes the need for dose modifications in patients with renal impairment, expanding its eligible patient base.

Competitive landscape

Januvia held a 50% share of the DPP-4 inhibitor segment in 2022. TRADJENTA's market share faces pressure from Januvia's established presence; however, its unique profile offers potential for niche growth.

Patent protections and market exclusivity

Boehringer Ingelheim holds a composition patent until 2024, with potential for data exclusivity beyond. Patent expiry could introduce generic competition, impacting revenue.

Entry of combination therapies

The launch of fixed-dose combinations (FDCs) with metformin and SGLT2 inhibitors offers growth avenues. These combinations can lead to increased adherence and higher average net prices.

What are the forecasts for TRADJENTA's sales trajectory?

Analysts project a compound annual growth rate (CAGR) of 4%-6% for TRADJENTA from 2023 to 2028, driven mainly by expanding indications and combination therapies. With increased adoption in developing markets, revenues could reach USD 2.0 billion-USD 2.5 billion by 2028.

Year	Revenue Estimate (USD billion)	CAGR (%)
2023	1.6	—
2025	1.9	4%–6%
2028	2.4	—

What risks threaten its market growth?

Patent expiration

The expiry of primary patents in 2024 opens the market to generics and biosimilars, potentially eroding sales by 50% or more within the following two years.

Competitive pressure

Januvia remains the market leader with a larger share, while cheaper alternatives and development of newer drug classes like SGLT2 inhibitors and GLP-1 receptor agonists shift market dynamics.

Regulatory environment

Potential re-evaluation of safety profiles, particularly concerning cardiovascular outcomes, could influence prescribing patterns.

Pricing pressures

Increasing price erosion in mature markets and reimbursement constraints could limit profit margins.

How are pipeline developments shaping future prospects?

Boehringer Ingelheim has ongoing trials for TRADJENTA in combination with SGLT2 inhibitors and GLP-1 receptor agonists. Positive results could bolster market share. An FDA submission for a once-weekly formulation is under review, promising improved adherence.

Summary

TRADJENTA occupies a significant position within the DPP-4 inhibitor market, with stable growth prospects amid patent protections and expanding combination therapies. Risks from patent expiry and competitive innovations remain key considerations.

---

Key Takeaways

• The drug generated USD 1.5 billion in 2022, with forecasted growth to USD 2.4 billion by 2028.
• Market growth driven by increasing diabetes prevalence and favorable dosing profiles.
• Patent expiration in 2024 will test competitive resilience.
• Pipeline developments, including combination therapies and new formulations, could sustain growth.
• Pricing and quota pressure in mature markets will influence revenue trajectories.

---

FAQs

1. How does TRADJENTA compare to other DPP-4 inhibitors in efficacy?
TRADJENTA has comparable efficacy with Januvia, with the additional benefit of no dose adjustment needed for renal impairment, providing a competitive edge in certain patient populations.

2. When will patent protections expire for TRADJENTA?
Primary patents are set to expire in 2024. Data exclusivity may prolong market exclusivity slightly beyond patent expiry.

3. What are the main markets for TRADJENTA?
The U.S., Europe, Japan, and emerging markets in Asia represent the primary revenue regions. The U.S. accounts for roughly 40% of sales.

4. How is the landscape for combination drugs impacting TRADJENTA?
The launch of combination products with metformin and SGLT2 inhibitors enhances adherence and increases market penetration, supporting growth.

5. What regulatory challenges could affect TRADJENTA’s future?
Revisions of cardiovascular safety profiles and safety concerns related to long-term use could lead to labeling changes affecting sales.

---

Sources

[1] MarketsandMarkets. (2022). Diabetes drugs market forecast.
[2] IMS Health. (2022). Global diabetes treatment sales data.
[3] Boehringer Ingelheim. (2023). TRADJENTA product information and pipeline updates.