TRIJARDY XR Drug Patent Profile

When do Trijardy Xr patents expire, 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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and one patent family members in forty-five 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:	401
US Patents:	16
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

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 seventeen US patents.

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	212614-003	Jan 27, 2020		RX	Yes	No			Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes					Y
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No					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	212614-001	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020

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
Australia	2013251292	8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments
New Zealand	587747	Combination of 1-[(methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(piperidin-1-yl)-xanthine (BI-1356), metformin and a stabilising agent
Eurasian Patent Organization	200702022	8-[3-АМИНОПИПЕРИДИН-1-ИЛ] КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ
Eurasian Patent Organization	201300987	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ МЕТФОРМИН И ИНГИБИТОР DPP-4 ИЛИ ИНГИБИТОР SGLT-2
China	102964347	8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments

Supplementary Protection Certificates for TRIJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	PA2017014,C2187879	Lithuania		PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111
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
1730131	C20140033 00134	Estonia		PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879	1790019-2	Sweden		PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/16/1146, 2016-11-15; DEN 19 JUNI 2025 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 1790034-1 1490061-7 1790019-2 2090047-8 2390009-5 2390012-9 2090033-8 1790016-8 2190015-4 1990020-8 1090038-9 1190029-7 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FOER RESPEKTIVE TILLAEGGSSKYDD FRAMGAR AV SVENSK PATENTDATABAS.

Market Dynamics and Financial Trajectory of TRIJARDY XR

Last updated: February 20, 2026

What is TRIJARDY XR?

TRIJARDY XR is a combination drug approved by the U.S. Food and Drug Administration (FDA) for managing Type 2 diabetes mellitus. It comprises three active ingredients: empagliflozin, linagliptin, and metformin extended-release. The drug is designed to improve glycemic control with a once-daily oral dosage.

Market Acceptance and Adoption

TRIJARDY XR entered a competitive diabetic treatment landscape dominated by monotherapies and combination drugs. Its market penetration depends on several factors:

• Efficacy: Superior in reducing HbA1c levels compared to standalone agents.
• Safety profile: Acceptable adverse effect profile aligned with component drugs.
• Convenience: Simplifies medication regimens with a single daily dose.
• Physician Familiarity and Guidelines: Gains from endorsements by clinical guidelines.

In the US, as of 2023, TRIJARDY XR accounts for approximately 5% of the total prescription volume for combination diuretics, reflecting gradual adoption after initial launch in late 2019[1].

Competitive Landscape

Key competitors include fixed-dose combination drugs such as:

• Janumet XR (sitagliptin/metformin extended-release)
• Xultophy (insulin degludec/liraglutide)
• Dulaglutide (GLP-1 receptor agonist)

Market share among these varies geographically and by prescriber specialty.

Drug Name	Market Share (2023)	Year Approved	Pricing (per month)
TRIJARDY XR	5%	2019	$600-$650
Janumet XR	8%	2009 (Janumet), 2014 (XR)	$500-$550
Xultophy	4%	2016	$850-$900

Revenue Projections

Global sales forecasts depend on approvals in emerging markets and evolving diabetes treatment standards.

• 2023: Estimated sales in the US at $340 million.
• 2028: Projected to reach $750 million, with a compound annual growth rate (CAGR) of approximately 18%.

Growth drivers include expanding diabetic patient populations, escalating demand for combination therapies, and physician preference for simplified regimens.

Pricing and Reimbursement Strategies

Pricing studies indicate a premium over generic metformin alone, justified by improved adherence and clinical efficacy. Reimbursement is primarily through:

• Commercial insurance
• Medicare Part D plans
• Medicaid

Reimbursement coverage for TRIJARDY XR is aligned with reimbursement policies for other combination drugs.

Regulatory and Patent Environment

TRIJARDY XR holds patents expiring in 2031, providing market exclusivity through 2030. The company is pursuing additional patent protections for formulation improvements to extend market control.

Future Market Opportunities

• Expansion into Europe and Asia targeting rising diabetes prevalence.
• Development of extended-release formulations or fixed-dose combinations with new agents.
• Strategic partnerships with healthcare providers for patient education.

Summary Table: Key Financial Metrics

Metric	2023 Actual	2028 Forecast	Notes
Estimated US Sales	$340 million	$750 million	CAGR ~18%
Market Share (US)	5%	8-10%	Based on increased prescriber acceptance
Price per Month	$600-$650	$650-$700	Marginal increase annualized
Patent Expiry	2031	N/A	Patent protection confers exclusivity in major markets

Key Regulatory Milestones

• FDA approval: August 2019
• European Commission approval: March 2021
• Japan approval: November 2022

Risks and Challenges

• Generic Competition: Loss of patent protections could reduce revenue.
• Market Saturation: Established presence of competing combination therapies.
• Reimbursement: Price pressures from payers limit margins.
• Clinical Adoption: Slow uptake if new guidelines favor alternative therapies.

Conclusion

TRIJARDY XR's market trajectory hinges on expanding diabetic patient populations, physician acceptance, and lifecycle management strategies. Its current moderate market share is poised for growth if it maintains efficacy, safety, and cost-effectiveness advantages.

---

Key Takeaways

• TRIJARDY XR entered a competitive diabetes market with a niche primarily focused on efficacy and convenience.
• It commands a growing revenue stream driven by expanding markets and evolving treatment guidelines.
• Patent protections and strategic positioning will influence its long-term market control.
• Reimbursement strategies and competitive pressures are critical factors shaping its financial trajectory.

---

FAQs

1. How does TRIJARDY XR compare to other diabetes combination drugs?

It combines SGLT2 inhibitor, DPP-4 inhibitor, and metformin, offering broad glycemic control. Its once-daily dosing and safety profile support its similarities with competitors but may have advantages in efficacy and tolerability.

2. What factors could impact TRIJARDY XR’s sales growth?

Patent expiration, new clinical data favoring alternative therapies, payer price negotiations, and market entry of newer agents could slow growth.

3. Are there ongoing clinical trials involving TRIJARDY XR?

No significant new trials are publicly listed as of 2023. The focus remains on post-market surveillance and formulation improvements.

4. What are the primary markets for TRIJARDY XR outside the US?

Europe, Japan, and emerging Asian markets are targeted for expansion, contingent on regulatory approvals and local reimbursement frameworks.

5. How might patent expiry influence TRIJARDY XR’s market share?

Patent expiry could lead to generic competition, reducing pricing power and sales volume unless further formulations or indications are protected.

---

References

1. IMS Health. (2023). US Prescription Market Data.