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 eighty-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 twenty-two 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:	486
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	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.

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.

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					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	212614-003	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	212614-004	Jan 27, 2020		RX	Yes	Yes
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	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	212614-002	Jan 27, 2020
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	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	212614-002	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	212614-001	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
Taiwan	201509941	New formulations, tablets comprising such formulations, their use and process for their preparation
Hong Kong	1081552	8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS
Ukraine	89040	ЗАМЕЩЕННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, ЛЕКАРСТВЕННОЕ СРЕДСТВО, КОТОРОЕ СОДЕРЖИТ ЭТИ СОЕДИНЕНИЯ;ЗАМІЩЕНІ ГЛЮКОПІРАНОЗИЛОМ БЕНЗОЛЬНІ ПОХІДНІ, ЛІКАРСЬКИЙ ЗАСІБ, ЯКИЙ МІСТИТЬ ЦІ СПОЛУКИ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS)
New Zealand	523214	A dosage form of a solid monolithic matrix non-circular in shape having first and second orthoganal axes of unequal length and that swells upon contact with water
Taiwan	I319320
Eurasian Patent Organization	011158	ЗАМЕЩЁННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩИЕ ЭТИ СОЕДИНЕНИЯ ЛЕКАРСТВЕННЫЕ СРЕДСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
Eurasian Patent Organization	201101191	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ИНГИБИТОР SGLT-2, ИНГИБИТОР ДПП-IV И НЕОБЯЗАТЕЛЬНО ДРУГОЙ АНТИДИАБЕТИЧЕСКИЙ АГЕНТ, И ЕЕ ПРИМЕНЕНИЕ

Supplementary Protection Certificates for TRIJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2187879	132017000050485	Italy		PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
2187879	2017/018	Ireland		PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131	568	Finland
1730131	C01730131/05	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1532149	118 5013-2011	Slovakia		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1532149	PA2011013	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

Market Dynamics and Financial Trajectory for Trijardy XR

Introduction to Trijardy XR

Trijardy XR, a triple-combination tablet, was approved by the U.S. Food and Drug Administration (FDA) in January 2020 for the treatment of type 2 diabetes in adults. This medication combines empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin hydrochloride extended release, making it a comprehensive treatment option for managing blood sugar levels along with diet and exercise[3][4].

Market Need and Target Audience

The approval of Trijardy XR addresses a significant need in the diabetes management market. Type 2 diabetes is a complex condition that often requires multiple medications to manage effectively. By providing three well-established medicines in one pill, Trijardy XR simplifies the treatment regimen for patients, particularly those who are already managing multiple medications and lifestyle changes[3].

Competitive Landscape

Trijardy XR operates within a competitive market that includes other type 2 diabetes treatments such as Farxiga, Glyxambi, Invokana, Janumet, Januvia, Jardiance, Segluromet, Steglatro, Steglujan, Synjardy, Tradjenta, and Xigduo. The market dynamics are influenced by the presence of these peer products, and Trijardy XR's success is benchmarked against these competitors[1].

Promotional Activities and Physician Engagement

In 2021, Trijardy XR engaged in significant promotional activities to reach physicians. Over 14,630 paid interactions across 7,840 physicians were recorded, including sales rep detailing, physician education, and paid speaking engagements. The median spend on these activities varied, with a focus on ensuring deep coverage within key specialties such as Family Medicine, Nursing, Internal Medicine, Physician Assistant, and Endocrinology. Physicians received paid meals for Trijardy XR, with the most frequent recipients and top paid speakers identified through CMS Open Payments data[1].

Financial Performance of Eli Lilly and Boehringer Ingelheim

The financial performance of Trijardy XR is closely tied to the overall financial health of its marketers, Eli Lilly and Company and Boehringer Ingelheim.

Eli Lilly's Financial Results

In the fourth quarter of 2023, Eli Lilly reported a 28% increase in revenue, driven largely by new products such as Mounjaro and Zepbound. While Trijardy XR is not explicitly highlighted as a major contributor to this growth, the overall strong financial performance of Eli Lilly indicates a robust market environment for its diabetes products[2].

In the third quarter of 2023, Eli Lilly's worldwide revenue increased by 37%, with growth products like Verzenio and Jardiance contributing significantly. This growth underscores the company's strong position in the diabetes market, which bodes well for Trijardy XR[5].

Research and Development Investments

Eli Lilly has been investing heavily in research and development, with a 28% increase in R&D expenses in the fourth quarter of 2023 compared to the previous year. This investment is crucial for maintaining innovation and competitiveness in the diabetes treatment market, including for products like Trijardy XR[2].

Market Insights and Benchmarking

Trijardy XR's performance is benchmarked against its peer products in the type 2 diabetes market. The analysis by MDDetails reveals that Trijardy XR reached a significant number of physicians through promotional activities, although the exact number of physicians reached and the comparative depth of coverage vary across different specialties. This benchmarking helps in understanding the market positioning and effectiveness of Trijardy XR's promotional strategies[1].

Patient and Physician Preferences

The convenience of a single pill containing three established medications is a key selling point for Trijardy XR. Patients and physicians alike appreciate the simplicity of this treatment regimen, which can improve adherence and reduce the complexity of managing type 2 diabetes.

Regulatory Approval and Clinical Trials

The FDA approval of Trijardy XR was based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and metformin hydrochloride extended release. This regulatory approval is a testament to the drug's efficacy and safety profile, further solidifying its position in the market[3].

Future Outlook and Market Projections

The global diabetes nutrition market, which includes type 2 diabetes treatments, is projected to grow significantly. By 2030, this market is expected to surpass $8.9 billion, with the type 2 diabetes segment holding a dominant position. This growth trend indicates a favorable market environment for Trijardy XR and other type 2 diabetes treatments[4].

Key Takeaways

• Comprehensive Treatment: Trijardy XR combines three established type 2 diabetes medications into one pill, simplifying treatment regimens for patients.
• Strong Promotional Activities: Significant promotional efforts, including sales rep detailing and paid speaking engagements, have been undertaken to engage physicians.
• Financial Performance: Eli Lilly's strong financial results, driven by new products and growth in the diabetes segment, support the market trajectory of Trijardy XR.
• Market Positioning: Benchmarking against peer products highlights Trijardy XR's competitive positioning in the type 2 diabetes market.
• Regulatory Approval: FDA approval based on clinical trials underscores the drug's efficacy and safety.

FAQs

1. What are the components of Trijardy XR?

   • Trijardy XR is a triple-combination tablet containing empagliflozin (Jardiance), linagliptin (Tradjenta), and metformin hydrochloride extended release[3].

2. When was Trijardy XR approved by the FDA?

   • Trijardy XR was approved by the FDA in January 2020[3].

3. How does Trijardy XR simplify diabetes management?

   • By combining three medications into one pill, Trijardy XR simplifies the treatment regimen for patients, improving adherence and reducing complexity[3].

4. What is the competitive landscape for Trijardy XR?

   • Trijardy XR competes with other type 2 diabetes treatments such as Farxiga, Glyxambi, Invokana, and others. Its performance is benchmarked against these peer products[1].

5. What are the projected market trends for type 2 diabetes treatments?

   • The global diabetes nutrition market, including type 2 diabetes treatments, is expected to surpass $8.9 billion by 2030, with type 2 diabetes segment holding a dominant position[4].

Sources

1. MDDetails: Trijardy XR 2021 report.
2. Eli Lilly Investor Relations: Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Financial Guidance.
3. PR Newswire: US FDA Approves Only Triple-Combination Tablet with Jardiance for Adults with Type 2 Diabetes.
4. GlobeNewswire: Diabetes Nutrition Market to Surpass US$ 8,920.9 Million by 2030, Says Coherent Market Insights (CMI).
5. Eli Lilly Investor Relations: Lilly Reports Third-Quarter 2023 Financial Results, Highlights Strong Sales Growth and Business Development Activity.

Last updated: 2024-12-16