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 four hundred and sixty-two 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:	462
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	10
Patent Applications:	1,604
Drug Prices:	Drug price information for TRADJENTA
Drug Sales Revenues:	Drug sales revenues 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	8,853,156*PED				Y
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes	8,846,695*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	6,303,661
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	8,119,648
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	6,890,898

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/002110 Trajenta 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
Chile	2012002527	Medio de aislamiento y conservación para islotes de langerhans o células beta, donde el medio que refuerza la vitalidad y la capacidad de secreción de las células contiene entre 1 nmol/l y 1 µmol/l de un inhibidor de dipeptidil peptidasa iv (dpp iv o cd26); procedimiento para reforzar la vitalidad y capacidad de secreción de islotes de langerhans o células beta durante la fase de aislamiento y transplante.
Croatia	P20100507
European Patent Office	2574336
South Korea	20170043674	메트포르민 요법이 부적합한 환자에서의 당뇨병 치료 (Treatment for diabetes in patients inappropriate for metformin therapy)

Supplementary Protection Certificates for TRADJENTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1532149	C01532149/01	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1084705	CA 2014 00065	Denmark		PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720

Market Dynamics and Financial Trajectory for Tradjenta

Introduction to Tradjenta

Tradjenta, also known by its generic name linagliptin, is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. Developed by Boehringer Ingelheim and marketed in collaboration with Eli Lilly, Tradjenta has been a significant player in the global diabetes market since its FDA approval in 2011[4].

Market Overview

The global DPP-4 inhibitors market, which includes Tradjenta, was valued at USD 10.5 billion in 2018 and is expected to grow at a CAGR of 4% from 2019 to 2024. This growth is driven by increasing prevalence of type 2 diabetes and obesity, as well as the rise in clinical trials for DPP-4 drugs[1].

Key Drivers

• Increasing Diabetes Prevalence: The dramatic increase in type 2 diabetes cases globally is a major driver for the growth of Tradjenta. According to recent data, the United States alone has about 38.4 million diabetes patients, with an additional 97.6 million adults classified as prediabetic, highlighting the growing demand for effective treatments[3].
• Clinical Efficacy and Combination Therapies: Tradjenta's efficacy in lowering blood glucose levels, combined with its use in combination therapies such as Jentadueto and Jentadueto XR (linagliptin and metformin hydrochloride), enhances its market appeal. Physicians' efforts to delay disease progression and reduce diabetic complications also boost the demand for such drugs[4].

Geographical Performance

• North America: This region holds the highest market share for DPP-4 inhibitors, including Tradjenta. The North American oral anti-diabetic drug market is expected to reach USD 18.76 billion by 2024 and grow at a CAGR of 4.70% from 2024 to 2029[3].
• Asia-Pacific and Latin America: These regions are also significant, with the Asia-Pacific holding 32% of the global DPP-4 market share. Latin America is expected to register the highest CAGR of approximately 6% during the forecast period[1].

Competitive Landscape

• Market Share: Tradjenta is expected to surpass Merck's Januvia (sitagliptin) in market share during the forecast period. In 2018, Merck held the highest market share, but the launch of generic versions of sitagliptin in 2022 is expected to reduce Merck's market dominance[1].
• Key Players: Besides Boehringer Ingelheim and Eli Lilly, other major players in the DPP-4 inhibitors market include AstraZeneca, Bristol Myers Squibb, Novartis, and Takeda Pharmaceuticals[1].

Financial Performance

• Revenue Growth: The global Tradjenta market is expected to register a CAGR of 5.7% from 2019 to 2024. This growth is reflected in the financial results of Eli Lilly, which has seen significant revenue increases driven by its diabetes portfolio, including Tradjenta. For instance, in Q2 2024, Eli Lilly reported a 36% increase in worldwide revenue, partly driven by the growth of its new products, although Tradjenta's specific contribution is not isolated in these reports[5].
• Combination Therapies: The combination of linagliptin with metformin hydrochloride in Jentadueto and Jentadueto XR has contributed to the financial success of Tradjenta. These combination therapies are popular due to their clinical efficacy and patient compliance[4].

Challenges and Restraints

• Generic Competition: The potential launch of generic versions of DPP-4 inhibitors, such as sitagliptin, could impact the market share and revenue of branded drugs like Tradjenta. However, Tradjenta's unique profile and combination therapies may help it maintain its market position[1].
• Regulatory Decisions: In some regions, regulatory decisions can affect the market performance of drugs. For example, Tradjenta was not launched in Germany due to a decision by the country's reimbursement authority that it did not provide additional benefits compared to existing medications[1].

Future Trends and Opportunities

• Increasing Clinical Trials: The increase in clinical trials for DPP-4 inhibitors is expected to boost market growth. These trials often explore new indications and combination therapies, which can expand the market for Tradjenta[1].
• Growing Demand in Emerging Markets: The rising prevalence of diabetes in emerging countries presents significant opportunities for growth. The Asia-Pacific and Latin American regions are expected to drive future market expansion[1].

Key Takeaways

• Tradjenta is poised to surpass Januvia in market share due to its strong growth trajectory.
• The drug benefits from increasing diabetes prevalence and the preference for combination therapies.
• North America and the Asia-Pacific are key regions driving the market growth.
• Generic competition and regulatory decisions are potential challenges.
• Future growth is expected to be driven by increasing clinical trials and demand in emerging markets.

FAQs

Q: What is Tradjenta used for? A: Tradjenta (linagliptin) is used in the treatment of type 2 diabetes to lower blood glucose levels.

Q: Who are the key players in the DPP-4 inhibitors market? A: Key players include Boehringer Ingelheim, Eli Lilly, Merck, AstraZeneca, Bristol Myers Squibb, Novartis, and Takeda Pharmaceuticals.

Q: What is the expected CAGR for the global Tradjenta market from 2019 to 2024? A: The global Tradjenta market is expected to register a CAGR of 5.7% from 2019 to 2024.

Q: How does Tradjenta compare to other DPP-4 inhibitors in terms of market share? A: Tradjenta is expected to surpass Merck's Januvia in market share during the forecast period.

Q: What are the main drivers of growth for the Tradjenta market? A: The main drivers include the increasing prevalence of type 2 diabetes, clinical efficacy, and the use of combination therapies.

Cited Sources

1. Dipeptide Peptidase 4 (DPP-4) Inhibitors: Global Market 2019-2024 - ResearchAndMarkets.com
2. Lilly Reports Strong Fourth-Quarter 2023 Financial Results and ... - Eli Lilly Investor Relations
3. North America Oral Anti-Diabetic Drug Market Size & Share Analysis - Mordor Intelligence
4. Research and Markets: Tradjenta (Type 2 Diabetes) - Forecast and Market Analysis to 2022 - Business Wire
5. Lilly Reports Q2 2024 Financial Results, Raises Full-Year Revenue ... - Eli Lilly Investor Relations