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JENTADUETO Drug Patent Profile

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

Jentadueto is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-three patent family members in forty-five countries.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jentadueto

A generic version of JENTADUETO was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30^th, 2021.

Summary for JENTADUETO

International Patents:	373
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	34
Drug Prices:	Drug price information for JENTADUETO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JENTADUETO
What excipients (inactive ingredients) are in JENTADUETO?	JENTADUETO excipients list
DailyMed Link:	JENTADUETO at DailyMed

See drug prices for JENTADUETO

Recent Clinical Trials for JENTADUETO

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1

See all JENTADUETO clinical trials

Pharmacology for JENTADUETO

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Paragraph IV (Patent) Challenges for JENTADUETO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO	Tablets	linagliptin; metformin hydrochloride	2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg	201281	8	2015-05-04

US Patents and Regulatory Information for JENTADUETO

JENTADUETO is protected by nine 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	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,155,705*PED				Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	9,173,859*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	11,911,388
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	7,407,955*PED				Y

Expired US Patents for JENTADUETO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	8,119,648
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	6,303,661
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	8,119,648
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	6,303,661
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	8,119,648

EU/EMA Drug Approvals for JENTADUETO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jentadueto	linagliptin, metformin hydrochloride	EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.	Authorised	no	no	no	2012-07-19

International Patents for JENTADUETO

When does loss-of-exclusivity occur for JENTADUETO?

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 JENTADUETO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013199505	USE OF DPP-IV INHIBITOR
Ukraine	97468	КОМБИНАЦИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ СОДЕРЖИТ 8-[3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННОГО СРЕДСТВА;КОМБІНАЦІЯ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ 8-[3-АМІНОПІПЕРИДИН-1-ІЛ]КСАНТИНИ, СПОСІБ ЇЇ ОДЕРЖАННЯ ТА ЇХ ЗАСТОСУВАННЯ ЯК ЛІКАРСЬКОГО ЗАСОБУ (COMBINATION AND PHARMACEUTICAL COMPOSITION COMPRISING 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES, PROCESS FOR THE PREPARATION THEREOF AND USE AS MEDICAMENT)
European Patent Office	2058311	8-[3-amino-pipéridine-1-yl]-xanthine, leur fabrication et leur utilisation en tant que médicament (8-[3-amino-piperidin-1-yl]-xanthins, their production and utilisation as medicine)
China	101460173	Uses of DPP-IV inhibitors
Ecuador	SP11010971	TRATAMIENTO DE LA DIABETES EN PACIENTES CON CONTROL GLUCEMICO INSUFICIENTE A PESAR DE LA TERAPIA CON UN FÁRMACO ORAL O NO ORAL ANTIDIABÉTICO

Supplementary Protection Certificates for JENTADUETO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1532149	C01532149/01	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
1532149	C20110018 00046	Estonia		PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
0896538	07C0035	France		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720

JENTADUETO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for JENTADUETO

Introduction to JENTADUETO

JENTADUETO, a combination of linagliptin (Tradjenta) and metformin hydrochloride, is a significant medication in the treatment of type 2 diabetes. Developed by Boehringer Ingelheim and Eli Lilly and Company, this drug has been approved by regulatory bodies in several regions, including the U.S. FDA and the European Medicines Agency (EMA)[4].

Market Overview

The global market for Dipeptide Peptidase 4 (DPP-4) inhibitors, which includes JENTADUETO, was valued at USD 10.5 billion in 2018. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2019 to 2024[1].

Drivers of Market Growth

Several factors are driving the growth of the DPP-4 inhibitors market, including JENTADUETO:

Increasing Prevalence of Type 2 Diabetes

The rising prevalence of type 2 diabetes globally is a significant driver. As the population ages and obesity rates increase, the demand for effective diabetes treatments like JENTADUETO is expected to rise[1].

Clinical Trials and Regulatory Approvals

Positive outcomes from clinical trials and regulatory approvals in various regions have boosted the market. For instance, JENTADUETO was recommended for approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) and approved by the U.S. FDA, which has expanded its market reach[4].

Combination Therapy Benefits

JENTADUETO offers the convenience of a single-tablet combination therapy, which improves patient compliance and glycemic control. This combination of linagliptin and metformin has shown superior efficacy compared to metformin monotherapy and placebo in clinical studies[4].

Geographical Performance

North America

North America holds the highest market share in the DPP-4 inhibitors market, driven by high diabetes prevalence and advanced healthcare infrastructure. JENTADUETO, marketed as Tradjenta in the U.S., benefits from this strong market presence[1].

Europe and Other Regions

In Europe, JENTADUETO is marketed as Trajenta, and it has seen significant sales growth. The drug is also available in other regions, including Canada and Japan, where it is known as Trazenta[4].

Financial Performance

Revenue Growth

JENTADUETO, along with its component Tradjenta, has contributed significantly to the revenue of Boehringer Ingelheim and Eli Lilly. In 2018, Tradjenta/Jentadueto generated net sales of EUR 1,397 million (approximately USD 1.5 billion), with a 5% increase from the previous year[2].

Recent Financial Highlights

In 2022, the combined sales of Tradjenta/Jentadueto reached $1,794 million, reflecting continued demand for the medication. This growth is part of Boehringer Ingelheim's overall strong financial performance, with net sales increasing by 17% compared to 2021[5].

Competitive Landscape

Market Share and Competition

Merck's Januvia (Sitagliptin) has historically held the maximum market share in the DPP-4 inhibitors market. However, the Tradjenta market, including JENTADUETO, is expected to surpass Januvia during the forecast period due to its strong growth trajectory[1].

Generic Competition

The launch of generic versions of other DPP-4 inhibitors, such as Sitagliptin in 2022, may impact the market share of branded drugs. However, JENTADUETO's unique combination and strong clinical profile are expected to maintain its market position[1].

Future Trends and Opportunities

Increasing Demand for Combination Therapies

The trend towards combination therapies in diabetes treatment is expected to continue, driving demand for JENTADUETO. As more patients require multiple treatments to manage their blood sugar levels, the convenience and efficacy of JENTADUETO will remain a key selling point[4].

Expanding into Emerging Markets

Latin America is expected to register the highest CAGR in the DPP-4 inhibitors market, presenting a significant opportunity for JENTADUETO to expand its market reach in emerging economies[1].

Challenges and Restraints

Regulatory Hurdles

In some regions, regulatory decisions can impact the market. 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 over existing medications[1].

Generic Competition and Patent Expirations

The potential launch of generic versions of DPP-4 inhibitors can reduce the market share of branded drugs. However, JENTADUETO's combination therapy and ongoing clinical trials may help mitigate this impact[1].

Key Takeaways

• JENTADUETO is a significant player in the DPP-4 inhibitors market, driven by its efficacy and convenience as a combination therapy.
• The drug has seen strong revenue growth and is expected to continue this trajectory.
• Geographical expansion, especially in emerging markets, presents a significant opportunity.
• Regulatory approvals and clinical trial outcomes are crucial for maintaining market position.
• Generic competition and patent expirations are key challenges to be addressed.

FAQs

What is JENTADUETO, and how is it used?

JENTADUETO is a combination of linagliptin (Tradjenta) and metformin hydrochloride, used to improve glycemic control in adults with type 2 diabetes. It is taken as a single tablet, twice daily, along with diet and exercise[4].

Which regions have approved JENTADUETO?

JENTADUETO has been approved by the U.S. FDA and the European Medicines Agency (EMA) and is available in various regions including the U.S., Europe, Canada, and Japan[4].

How does JENTADUETO compare to other DPP-4 inhibitors?

JENTADUETO is expected to surpass Merck's Januvia in market share during the forecast period due to its strong growth trajectory and the benefits of its combination therapy[1].

What are the key drivers of the market growth for JENTADUETO?

The increasing prevalence of type 2 diabetes, clinical trials, and regulatory approvals are significant drivers of market growth for JENTADUETO[1].

What challenges does JENTADUETO face in the market?

JENTADUETO faces challenges such as regulatory hurdles, generic competition, and patent expirations, which can impact its market share and revenue[1].

Cited Sources:

1. Dipeptide Peptidase 4 (DPP-4) Inhibitors: Global Market 2019-2024 - ResearchAndMarkets.com
2. Boehringer Ingelheim 2018 Annual Report - Annual Reports
3. Lilly Annual Report 2012 - Eli Lilly and Company
4. Jentadueto (linagliptin/metformin hydrochloride) tablets recommended for approval in the treatment of adults with type 2 diabetes in Europe - PR Newswire
5. Boehringer Ingelheim 2023: Facing down uncertainty - PharmaLive