QTERNMET XR Drug Patent Profile

When do Qternmet Xr patents expire, and when can generic versions of Qternmet Xr launch?

Qternmet Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and ninety-two patent family members in forty-eight countries.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Qternmet Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 12, 2031. This may change due to patent challenges or generic licensing.

There have been eighteen 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 QTERNMET XR

International Patents:	292
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QTERNMET XR
DailyMed Link:	QTERNMET XR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QTERNMET XR

Constraining patent/regulatory exclusivity:

9,616,028*PED

NDA:

210874

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.

US Patents and Regulatory Information for QTERNMET XR

QTERNMET XR is protected by five US patents.

This potential generic entry date is based on patent 9,616,028.

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
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	7,919,598*PED				Y

Expired US Patents for QTERNMET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	8,628,799
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	6,414,126
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	9,198,925

International Patents for QTERNMET XR

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

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

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 QTERNMET XR around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2583920	КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (BI-LAYER TABLET COMPOSITION)
Norway	20065870
South Korea	101502292

Supplementary Protection Certificates for QTERNMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	2012C/016	Belgium		PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
2498758	CA 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113

Market Dynamics and Financial Trajectory for QTERNMET XR

Last updated: January 1, 2026

Executive Summary

QTERNMET XR (sitagliptin/metformin extended-release) is a combination oral antidiabetic medication approved by the FDA in 2017. As a dual-action treatment for type 2 diabetes mellitus (T2DM), it capitalizes on increasing demand for effective, convenient therapies amid a growing diabetic population globally. This analysis explores the current market landscape, competitive positioning, revenue potential, regulatory environment, manufacturing considerations, and future prospects of QTERNMET XR, providing insights for stakeholders seeking strategic investment and partnership opportunities.

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What Is QTERNMET XR and How Does It Fit into the T2DM Market?

QTERNMET XR combines sitagliptin, a DPP-4 inhibitor, with metformin extended-release, a cornerstone in T2DM management. Its formulation offers the convenience of a single daily dose, improving patient adherence.

Component	Mechanism of Action	Benefit
Sitagliptin	Enhances incretin levels, stimulating insulin secretion	Improved glycemic control with low hypoglycemia risk
Metformin XR	Suppresses hepatic glucose production	First-line therapy, weight-neutral or weight-loss effects

This combination targets the core pathophysiology of T2DM, aligning with ADA and EASD treatment guidelines.

Current Market Landscape

Global and U.S. Market Size

• The global T2DM pharmaceutical market was valued at approximately $45 billion in 2022, projected to grow at a CAGR of 7–9% through 2030 [1].
• The U.S. accounts for over 40% of the global market, with sales exceeding $20 billion in 2022.

Competitive Landscape

Key competitors include:

Product	Drug Class	Approval Year	Market Position	Features
Janumet XR	Sitagliptin and metformin (dual)	2013	Market Leader	Established, multiple formulations
Dascynmet (generic)	Generic combinations	2010s	Price-sensitive segment	Lower cost, high volume
Bydureon (exenatide)	GLP-1 receptor agonist	2015	Growth segment	Different mechanism, injectables
SGLT2 inhibitors (e.g., Jardiance, Invokana)	SGLT2 inhibitors	2014–2018	Expanding segment	Cardio-renal benefits, oral agents

QTERNMET XR's unique selling point is its fixed-dose combination with extended-release, offering improved adherence over immediate-release counterparts.

Market Penetration and Adoption Trends

While market penetration remains moderate due to existing entrenched competitors, the increasing emphasis on combination therapies and patient compliance elevates QTERNMET XR's potential. Adoption is facilitated by:

• Prescriber preference for simplified regimens.
• Insurance payer coverage expanding under formulary inclusions.
• Aging populations increasing T2DM prevalence.

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Regulatory and Patent Environment

Regulation Synopsis

• FDA Approval: 2017, under New Drug Application (NDA) process.
• EMA Status: Not yet approved; potential for European expansion.
• Orphan Drug Status: Not applicable.

Patent Landscape

• Patent protection achieved via formulation, method of use, and manufacturing process patents.
• Last patent expiry expected around 2027–2028 [2], allowing generic competition thereafter.
• Recent patent challenges could impact exclusivity timelines.

Pricing Policies

• Average wholesale price (AWP): Approximately $300–$350 per month.
• Negotiated discounts and rebates by payers influence actual revenue.

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Manufacturing and Supply Chain Considerations

• Manufacturing: Requires quality control compliant with cGMP standards.
• Supply Chain: Dependence on active pharmaceutical ingredients (APIs) supply chain stability.
• Distribution: Wide-reaching distribution networks necessary for global reach.

Contingencies include raw material shortages affecting production timelines.

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Financial Trajectory Projections

Revenue Forecasts (2023–2030)

Year	Estimated Global Sales	Assumptions
2023	$150 million	Initial market penetration, moderate growth
2025	$300 million	Increased prescriber acceptance, expanded indications
2028	$600 million	Near patent expiry, generic presence begins
2030	$750 million	Market maturation, dosing optimization

Key Growth Drivers

• Population Growth: An estimated 700 million people with T2DM globally in 2023 [3].
• Treatment Guidelines: Favor the combination therapy for early and maintenance treatment.
• Pricing Strategy: Premium pricing justified by improved compliance and outcomes.

Risks and Challenges

• Patent Cliff: Expiry around 2027–2028 reducing exclusivity and revenue.
• Market Competition: Emergence of more effective or safer agents.
• Regulatory Changes: Price controls and reimbursement policies.

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Strategic Opportunities and Challenges

Opportunity	Challenge
Expanding to international markets	Regulatory barriers in Europe and Asia
Formulation innovations (e.g., single-pill combinations)	High development costs for new formulations
Strategic partnerships for marketing	Competition from well-established brands
Leveraging real-world evidence (RWE)	Demonstrating clinical superiority

Future Outlook

The increasing global burden of T2DM, coupled with demand for simplified regimens, positions QTERNMET XR for sustained growth in the coming years. However, its success hinges on navigating patent expirations, expanding payer coverage, and differentiating from competitors.

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Comparison with Competitors

Feature	QTERNMET XR	Janumet XR	Dascynmet (generic)	SGLT2 inhibitors	GLP-1 agents
Dose Convenience	Once daily	Once daily	Once or twice daily	Once daily	Weekly or daily injections
Cost	Premium	Premium	Low-cost	Moderate to high	High
Efficacy	Strong	Strong	Similar	Cardiovascular benefits	Weight loss, CV benefits
Side Effects	Mild, GI, hypoglycemia	Mild	Similar	Genital infections	Gastrointestinal, injection site reactions

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Key Takeaways

• Market Positioning: QTERNMET XR fills a niche for convenient dual therapy in T2DM, capitalizing on the growing demand for adherence-friendly treatments.
• Revenue Potential: With projected global sales reaching $600–750 million by 2030, strategic expansions and patent protections are critical.
• Competitive Landscape: Dominated by established monotherapies and advanced agents like SGLT2 inhibitors and GLP-1 receptor agonists; differentiation is key.
• Regulatory and Patent Risks: Patent expiration around 2027 may erode profitability, necessitating innovation or market differentiation.
• Global Strategy: Expansion into emerging markets offers significant growth but involves regulatory and logistical hurdles.
• Pricing and Payer Dynamics: Payer negotiations and formulary placements will significantly impact revenue realization.

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FAQs

1. When is the patent for QTERNMET XR expected to expire, and what are its implications?
Patent protection is projected to expire around 2027–2028. Post-expiry, generic competition is likely to reduce prices and margins, urging the manufacturer to innovate or diversify its portfolio.

2. How does QTERNMET XR compare in efficacy and safety to other combination therapies?
Clinical trials indicate comparable efficacy to other DPP-4 inhibitor/metformin combinations, with a safety profile characterized by mild gastrointestinal and hypoglycemic events. Its extended-release formulation improves adherence.

3. What are the major therapeutic advantages of QTERNMET XR?
Convenience through once-daily dosing, improved adherence, and dual-action mechanisms targeting different aspects of T2DM pathophysiology.

4. What markets should manufacturers target for expansion?
Asia-Pacific, Latin America, and Eastern Europe represent high-growth opportunities due to rising T2DM prevalence and improving healthcare infrastructure.

5. How will emerging therapies affect QTERNMET XR’s market share?
Innovative agents like SGLT2 inhibitors and GLP-1 receptor agonists offer additional benefits (e.g., cardiovascular risk reduction), potentially diminishing demand for traditional oral combinations unless QTERNMET XR can demonstrate comparable or superior outcomes.

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References

[1] GlobalData, "Diabetes Medications Market Forecast," 2022.
[2] U.S. Patent and Trademark Office, Patent filings related to sitagliptin/metformin formulations, 2017–2022.
[3] International Diabetes Federation, "IDF Diabetes Atlas," 10th ed., 2021.