JENTADUETO XR Drug Patent Profile

Which patents cover Jentadueto Xr, and what generic alternatives are available?

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

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

The generic ingredient in JENTADUETO XR 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 Xr

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

Summary for JENTADUETO XR

International Patents:	375
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	34
Drug Prices:	Drug price information for JENTADUETO XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JENTADUETO XR
What excipients (inactive ingredients) are in JENTADUETO XR?	JENTADUETO XR excipients list
DailyMed Link:	JENTADUETO XR at DailyMed

See drug prices for JENTADUETO XR

Recent Clinical Trials for JENTADUETO XR

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1

See all JENTADUETO XR clinical trials

Pharmacology for JENTADUETO XR

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

Paragraph IV (Patent) Challenges for JENTADUETO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO XR	Extended-release Tablets	linagliptin; metformin hydrochloride	2.5 mg/1000 mg 5 mg/1000 mg	208026	1	2018-03-28

US Patents and Regulatory Information for JENTADUETO XR

JENTADUETO XR 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	11,911,388
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	8,673,927*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	8,673,927*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,415,016*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	8,883,805*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,155,705*PED				Y

Expired US Patents for JENTADUETO XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	6,488,962
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	7,078,381
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	6,890,898
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	7,459,428
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	8,178,541
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016	6,303,661
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016	6,340,475

EU/EMA Drug Approvals for JENTADUETO XR

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 XR

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

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Japan

Mexico

Philippines

Singapore

South Korea

Taiwan

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 XR around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	060757	USOS DE INHIBIDORES DE DPP IV
Eurasian Patent Organization	016166	8-[3-АМИНОПИПЕРИДИН-1-ИЛ]КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PREPARATION THEREOF AND THEIR USE AS PHARMACEUTICAL COMPOSITIONS)
Brazil	PI0911273
Japan	2000513028
World Intellectual Property Organization (WIPO)	9938501
European Patent Office	2287164	Procédé pour la préparation des 8-(3-aminopiperidin-1-yl)-xanthines chirales (Process for the manufacture of chiral 8-(3-aminopiperidin-1-yl)-xanthines)
Canada	2819705	PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO)

Supplementary Protection Certificates for JENTADUETO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	C20110018 00046	Estonia		PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1084705	PA2014045	Lithuania		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705	CR 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
1084705	SPC/GB14/083	United Kingdom		PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1084705	CR 2014 00062	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005

Market Dynamics and Financial Trajectory for JENTADUETO XR

Introduction to JENTADUETO XR

JENTADUETO XR is a prescription medication that combines two diabetes medicines, linagliptin and metformin hydrochloride extended-release, for the treatment of type 2 diabetes in adults. This drug is marketed by Boehringer Ingelheim and Eli Lilly and Company, and it represents a significant advancement in the management of type 2 diabetes due to its once-daily dosing convenience[1].

Market Overview

The global market for dipeptidyl peptidase-4 (DPP-4) inhibitors, which includes JENTADUETO XR, 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. The North American segment holds the highest revenue share, while Latin America is projected to register the highest CAGR during this period[4].

Drivers of Market Growth

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

Increasing Prevalence of Type 2 Diabetes

The global prevalence of type 2 diabetes is on the rise, driven by factors such as an aging population, increasing obesity rates, and sedentary lifestyles. Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes, with type 2 diabetes accounting for 90-95% of all diagnosed adult cases in the U.S.[1].

Clinical Trials and Research

Ongoing clinical trials and research on DPP-4 inhibitors are expected to boost market growth. These trials aim to improve the efficacy and safety profiles of these drugs, making them more attractive to healthcare providers and patients[4].

Convenience and Efficacy

JENTADUETO XR offers the convenience of a once-daily combination pill, which can improve patient adherence to treatment regimens. The combination of linagliptin and metformin provides a synergistic effect in lowering blood sugar levels, making it an effective treatment option for type 2 diabetes[1].

Restraints and Challenges

Despite the growth potential, there are several challenges facing the market:

Competition from Generic Versions

The DPP-4 inhibitors market is expected to face competition from generic versions of existing drugs. For example, the launch of a generic version of sitagliptin (Januvia) in 2022 is anticipated to impact the market share of branded DPP-4 inhibitors[4].

Regulatory and Safety Concerns

JENTADUETO XR carries a boxed warning for the risk of lactic acidosis, a serious metabolic complication associated with metformin accumulation. This warning, along with contraindications in patients with significant renal impairment, can affect its adoption and usage[1][5].

Financial Performance and Projections

The financial performance of JENTADUETO XR is closely tied to the overall performance of its parent companies and the broader DPP-4 inhibitors market.

Revenue and Market Share

The Tradjenta market, which includes JENTADUETO XR, is expected to register a CAGR of 5.7% during the forecast period of 2019-2024. This growth is anticipated to help Tradjenta surpass Januvia in market share by the end of the forecast period[4].

Company Financials

Eli Lilly and Company, one of the marketers of JENTADUETO XR, reported significant revenues from its diabetes portfolio. For instance, in the second quarter of 2016, Lilly's revenues from Jardiance, another diabetes medication, were $40.1 million, indicating strong financial performance in the diabetes segment[2].

Geographical Market Segmentation

The global DPP-4 inhibitors market is segmented geographically, with different regions contributing to its growth:

North America

North America holds the highest market share due to high diabetes prevalence and advanced healthcare infrastructure. The region is expected to continue driving the market growth for DPP-4 inhibitors, including JENTADUETO XR[4].

Asia-Pacific and Latin America

The Asia-Pacific region accounts for a significant market share, driven by a large and growing population with increasing diabetes prevalence. Latin America is expected to register the highest CAGR during the forecast period due to rising healthcare spending and increasing awareness about diabetes management[4].

Competitive Landscape

The DPP-4 inhibitors market is highly competitive, with several major pharmaceutical companies vying for market share:

Key Players

Merck and Co. held the highest market share in 2018 with its drug Januvia, but is expected to face competition from other players like Eli Lilly and Boehringer Ingelheim, which market Tradjenta and JENTADUETO XR. Other key players include AstraZeneca, Bristol Myers Squibb, Novartis, and Takeda Pharmaceuticals[4].

Future Trends and Opportunities

The market for JENTADUETO XR and other DPP-4 inhibitors is expected to evolve with several trends and opportunities:

Increasing Focus on Combination Therapies

Combination therapies like JENTADUETO XR are gaining traction due to their convenience and efficacy. This trend is expected to continue, driving the growth of the DPP-4 inhibitors market[1].

Emerging Markets

Emerging markets, particularly in Asia-Pacific and Latin America, offer significant growth opportunities due to their large and growing populations with increasing healthcare needs[4].

Key Takeaways

• Growing Market: The global DPP-4 inhibitors market, including JENTADUETO XR, is expected to grow at a CAGR of 4% from 2019 to 2024.
• Convenience and Efficacy: JENTADUETO XR offers once-daily dosing and a synergistic effect in lowering blood sugar levels.
• Competition: The market faces competition from generic versions and other branded DPP-4 inhibitors.
• Geographical Growth: North America holds the highest market share, while Latin America is expected to register the highest CAGR.
• Future Trends: Combination therapies and emerging markets are key drivers of future growth.

FAQs

1. What is JENTADUETO XR used for?

JENTADUETO XR is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus[1].

2. What are the active ingredients in JENTADUETO XR?

JENTADUETO XR contains linagliptin and metformin hydrochloride extended-release[1].

3. What is the recommended dosing for JENTADUETO XR?

The recommended dosing for JENTADUETO XR is individualized, not exceeding the maximum daily dose of 5 mg linagliptin and 2000 mg metformin hydrochloride, taken once daily with a meal[5].

4. What are the potential side effects of JENTADUETO XR?

JENTADUETO XR carries a risk of lactic acidosis and pancreatitis, and it is contraindicated in patients with significant renal impairment[1][5].

5. How does JENTADUETO XR compare to other DPP-4 inhibitors in the market?

JENTADUETO XR is expected to register a CAGR of 5.7% during the forecast period, potentially surpassing Januvia in market share by the end of the forecast period[4].

Cited Sources:

1. U.S. FDA Approves Once-daily Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults. PR Newswire.
2. Lilly Reports Second-Quarter 2016 Results, Provides Financial Guidance. Eli Lilly and Company.
3. An Analysis on leveraging the patent cliff with drug sales worth USD 251 billion going off-patent and analysis of different drug pricing. Pharmaceuticals.gov.in.
4. Dipeptide Peptidase 4 (DPP-4) Inhibitors: Global Market 2019-2024. ResearchAndMarkets.com.
5. JENTADUETO XR Label. FDA.