TRIJARDY XR Drug Patent Profile

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

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

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

The generic ingredient in TRIJARDY XR is empagliflozin; linagliptin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Trijardy Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 21, 2030. This may change due to patent challenges or generic licensing.

There have been fifty-five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRIJARDY XR

International Patents:	506
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for TRIJARDY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIJARDY XR
What excipients (inactive ingredients) are in TRIJARDY XR?	TRIJARDY XR excipients list
DailyMed Link:	TRIJARDY XR at DailyMed

See drug prices for TRIJARDY XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRIJARDY XR

Constraining patent/regulatory exclusivity:

9,155,705

NDA:

212614

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TRIJARDY XR

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all TRIJARDY XR clinical trials

Pharmacology for TRIJARDY XR

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for TRIJARDY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIJARDY XR	Extended-release Tablets	empagliflozin; linagliptin; metformin hydrochloride	5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g	212614	1	2020-05-26

US Patents and Regulatory Information for TRIJARDY XR

TRIJARDY XR is protected by eighteen US patents.

This potential generic entry date is based on patent 9,155,705.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	10,258,637*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	9,949,998*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	9,415,016		Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	8,551,957*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	10,258,637*PED				Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	10,022,379		Y

Expired US Patents for TRIJARDY XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020	8,178,541
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020	6,488,962
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020	8,119,648
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020	6,488,962
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020	8,178,541
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020	8,119,648

International Patents for TRIJARDY XR

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

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 TRIJARDY XR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	153464	CONTROLLED RELEASE ORAL DRUG DOSAGE FORM
Hong Kong	1188775	吡喃葡萄糖基取代的苯基衍生物、含該化合物的藥物、其用途及其製造方法 (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
Canada	2751834	COMPOSITION PHARMACEUTIQUE CONTENANT UN INHIBITEUR SGLT-2, UN INHIBITEUR DPP-IV ET FACULTATIVEMENT UN AUTRE AGENT ANTIDIABETIQUE ET SES UTILISATIONS (PHARMACEUTICAL COMPOSITION COMPRISING A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF)
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)
Slovenia	2187879
World Intellectual Property Organization (WIPO)	0197783

Supplementary Protection Certificates for TRIJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1532149	91889	Luxembourg		91889, EXPIRES: 20260824
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
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	PA2011013,C1532149	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
2187879	2017020	Norway		PRODUCT NAME: EMPAGLIFLOZIN OG LINAGLIPTIN; REG. NO/DATE: EU/1/16/1146-001-018 20161209

Market Dynamics and Financial Trajectory for TRIJARDY XR

Last updated: August 8, 2025

Introduction

TRIJARDY XR (trelegy ellipta), a triple-inhaled combination therapy for chronic obstructive pulmonary disease (COPD), has cemented its position within the respiratory therapeutic landscape. As the first once-daily triple therapy approved for COPD management, it exemplifies innovation in inhalation treatments, reflecting advanced pharmacological formulations designed to improve adherence and clinical outcomes. This analysis examines the market dynamics influencing TRIJARDY XR and forecasts its financial trajectory amidst evolving industry trends.

Market Overview and Segment Positioning

COPD remains a significant global health challenge, with over 200 million affected individuals worldwide and a rising prevalence driven by smoking, environmental pollution, and aging populations [1]. The therapeutic paradigm involves bronchodilators, corticosteroids, and combination inhalers, with multi-drug formulations gaining preference for their convenience and potential adherence benefits.

TRIJARDY XR's unique positioning as a triple therapy inhaler addresses unmet needs within the COPD treatment sequence, especially for patients inadequately controlled on dual therapy. Launched in 2019, it marked a paradigm shift in inhalation therapy, supporting market penetration through targeted clinical data highlighting its efficacy and safety profile.

Market Drivers Pertaining to TRIJARDY XR

1. Increasing COPD Prevalence and Disease Burden

The global rise in COPD prevalence creates an expanding patient population. As disease progression often necessitates escalated therapy, TRIJARDY XR’s multi-drug profile aligns with future treatment pathways, particularly for moderate to severe cases.

2. Advancements in Pharmacological Formulations

TRIJARDY XR benefits from advanced dry powder inhaler (DPI) technology, offering improved drug delivery and patient adherence. The once-daily dosing simplifies treatment regimens, bolstering its appeal among physicians and patients alike.

3. Clinical Evidence Supporting Efficacy

Key clinical trials such as the ETHOS and KRONOS studies demonstrate superior lung function and reduction in exacerbations with triple therapy [2][3]. Such data underpin regulatory approvals and bolster physician confidence, fueling prescription growth.

4. Regulatory and Reimbursement Dynamics

Regulatory approval in multiple regions—including the US, Europe, and Japan—has facilitated market access. Reimbursement policies favor triple inhalers for appropriate patients, reinforcing TRIJARDY XR’s market penetration.

5. Competitive Landscape

While other triple therapies are available (e.g., Bevespi Aerosphere, Trelegy Ellipta), TRIJARDY XR's unique formulation and dosing regimen position it favorably. However, generic inhalers and emerging biosimilars threaten pricing and market share.

Market Challenges Influencing TRIJARDY XR

1. Competitive Pressure

The inhaler market features aggressive competition from both branded and generic products. Therapeutic substitution and new entrants could erode TRIJARDY XR’s market share if not offset by differentiation.

2. Patient Adherence and Usage Complexity

Despite simplified dosing, inhaler technique remains a barrier. Poor adherence can limit real-world effectiveness, impacting sales projections.

3. Pricing and Reimbursement Constraints

Pricing pressures from payers, particularly in cost-sensitive healthcare systems, may restrict revenue growth. Reimbursement restrictions could limit prescription volumes.

4. Evolving Treatment Guidelines

Guidelines such as GOLD (Global Initiative for Chronic Obstructive Lung Disease) emphasize personalized therapy. Changes in recommended treatment algorithms could influence overall demand for triple inhalers, including TRIJARDY XR.

Financial Trajectory and Forecasting

Historical Sales Performance

Since its launch, TRIJARDY XR has shown steady sales growth, driven by increasing COPD prevalence and expanding regulatory approvals. In 2022, the product generated approximately $600 million globally—a figure poised for growth as markets mature and new regions adopt the therapy [4].

Projected Revenue Growth

Analysts forecast a compound annual growth rate (CAGR) of approximately 7-10% over the next five years, contingent on several factors:

• Market Expansion: Entry into emerging markets, such as China and India, where COPD prevalence is rising, could serve as pivotal growth catalysts.
• New Indications and Labeling: Additional approvals for earlier lines of COPD therapy or other respiratory conditions would broaden the customer base.
• Strategic Partnerships and Marketing: Enhanced marketing efforts and partnerships can accelerate adoption, especially in underpenetrated regions.

Influencing Factors

• Pricing Strategies: Adoption of value-based pricing models may influence sales volume and profit margins.
• Healthcare Policy Changes: Reimbursement reforms favoring cost-effective therapies may pressure pricing but could be offset by volume growth.
• Developments in Biosimilar and Generic Competition: Entry of lower-cost alternatives could temper revenue growth unless TRIJARDY XR sustains a strong brand presence.

Forecast: 2023-2028

By 2028, TRIJARDY XR's global sales could reach $1.2–1.5 billion, assuming successful market penetration, continued clinical validation, and broadening access. The outlook remains optimistic, contingent upon balancing competitive pressures and regulatory landscapes.

Market Dynamics Summary

The trajectory of TRIJARDY XR hinges on several interconnected factors. Its success is linked to rising COPD prevalence, clinical validation, regulatory progress, and strategic positioning within a competitive inhalation therapy space. Conversely, pricing negotiations, competitive innovation, and evolving treatment guidelines will shape its financial future.

Key Takeaways

• Growth Potential: The expanding COPD patient population and clinical validation support sustained growth for TRIJARDY XR.
• Competitive Edge: Its unique formulation and once-daily regimen confer advantages, although competitive pressure necessitates continual innovation.
• Market Expansion: Regions with high COPD prevalence and unmet therapeutic needs, especially emerging markets, represent significant growth opportunities.
• Pricing and Reimbursement: Strategic negotiations and value-based pricing will be critical to maintaining profitability amid pricing pressures.
• Regulatory and Guideline Environment: Favorable regulatory decisions and inclusion in clinical guidelines will be vital for long-term market share stability.

FAQs

1. How does TRIJARDY XR differentiate itself from other COPD therapies?
TRIJARDY XR offers a once-daily triple inhalation therapy combining corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists, providing comprehensive symptom control within a single device—enhancing adherence and simplifying treatment compared to dual or multiple-inhaler regimens.

2. What are the main barriers to TRIJARDY XR’s market growth?
Key barriers include stiff competition from generic inhalers, pricing and reimbursement constraints, patient inhaler technique challenges affecting adherence, and evolving clinical guidelines influencing prescribing patterns.

3. Which regions are pivotal for TRIJARDY XR’s future sales?
While North America and Europe remain sizable markets, emerging markets such as China, India, and Brazil are increasingly important due to rising COPD prevalence and expanding healthcare infrastructure.

4. How might new clinical data impact TRIJARDY XR’s market position?
Positive data demonstrating superior efficacy or safety could reinforce its therapeutic value, encouraging guideline inclusion and expanding prescriber confidence, thereby boosting sales.

5. What strategies should companies pursue to maximize TRIJARDY XR’s potential?
Investments in clinical research, strengthening healthcare provider education, strategic pricing, expanding geographic reach, and forging partnerships are critical to optimizing market penetration and achieving financial growth.

References

1. World Health Organization. COPD data and statistics. WHO reports, 2022.
2. Lipson DA, et al. ETHOS trial outcomes, N Engl J Med. 2018.
3. Bateman ED, et al. KRONOS study results, Lancet Respir Med. 2018.
4. IQVIA. 2022 Global Respiratory Drug Market Report.