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 six patents protecting this drug.

This drug has three hundred and forty-nine 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 sixteen 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:	349
US Patents:	6
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 six 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	8,628,799		Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	8,628,799		Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	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	6,515,117*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	210874-002	May 2, 2019	RE44186
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	RE44186
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	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

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
Hungary	E062284
Singapore	152030	CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV AND METHOD
World Intellectual Property Organization (WIPO)	2008116179
New Zealand	589190
Japan	5313889
Brazil	PI0014722	compostos inibidores de sglt2, composição farmacêutica e uso dos referidos compostos

Supplementary Protection Certificates for QTERNMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C 2014 029	Romania		PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211	2013/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1261586	C300436	Netherlands		PRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1261586	4/2010	Austria		PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
2139494	SPC/GB20/028	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719
2498758	301040	Netherlands		PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113

Market Dynamics and Financial Trajectory for QTERNMET XR

Last updated: July 30, 2025

Introduction

QTERNMET XR, a pharmacological combination therapy developed by Eli Lilly and Company, integrates dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, with metformin extended-release (XR). Approved primarily for the management of type 2 diabetes mellitus (T2DM), QTERNMET XR addresses the growing global burden of diabetes by offering a once-daily oral treatment option. As the landscape of diabetes therapeutics evolves rapidly, understanding the market dynamics and financial trajectory surrounding QTERNMET XR is essential for stakeholders—including pharmaceutical firms, investors, healthcare providers, and policymakers—aiming to gauge its commercial potential and strategic positioning.

Market Landscape and Therapeutic Positioning

The global diabetes market patterns reveal tremendous growth, driven by increasing prevalence and expanding treatment indications. According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide had diabetes in 2021, with projections exceeding 700 million by 2045 [1].

Within this context, SGLT2 inhibitors—like dapagliflozin—have surged in popularity due to their proven cardiovascular and renal benefits, alongside glycemic control. The inclusion of dapagliflozin in fixed-dose combinations (FDCs) such as QTERNMET XR capitalizes on this trend, offering improved adherence, simplified dosing, and potentially enhanced patient outcomes.

Regulatory and Clinical Drivers

Approval of QTERNMET XR by the FDA in 2020 marked a crucial inflection point, enabling Eli Lilly to position it as a strategic enhancer of diabetes management regimens. Clinical trials (e.g., DURATION-8, DAPA-MET) demonstrated superior glycemic control, weight reduction, and cardiovascular risk mitigation relative to monotherapies or separate administration of its components [2].

These clinical advantages catalyze formulary inclusion and prescriber acceptance, reinforcing the drug’s market penetration potential.

Market Dynamics Influencing QTERNMET XR

1. Competitive Landscape

QTERNMET XR faces competition from several other fixed-dose combinations and solo agents. Notable rivals include Jardiance (empagliflozin) with metformin, Invokana (canagliflozin) combinations, and other SGLT2 inhibitor formulations. The competitive edge hinges on clinical efficacy, safety profiles, dosing convenience, and cost.

2. Pricing and Reimbursement

Pricing strategies are pivotal; Eli Lilly’s positioning of QTERNMET XR as a cost-effective, once-daily option influences insurer and payer adoption. Reimbursement policies, particularly in key markets like the U.S., often favor treatment algorithms that demonstrate value propositions—improving patient compliance and reducing long-term complications.

3. Prescriber and Patient Acceptance

Physician awareness of cardiovascular and renal benefits associated with SGLT2 inhibitors bolsters prescriber willingness. Patient adherence improves with simplified regimens; however, concerns around side effects and cost remain barriers.

4. Regulatory and Market Access Dynamics

Expanding indications, such as for weight management or cardiovascular protection, could broaden market scope. Conversely, regulatory hurdles—such as safety concerns like genital infections—pose challenges, emphasizing the need for comprehensive post-marketing surveillance.

5. Geographic Expansion

Market growth is heavily contingent on geographic dissemination. The U.S. remains the primary revenue driver, but increased penetration in Europe, Asia-Pacific, and Latin America, where diabetes prevalence surges, offers substantial upside.

Financial Trajectory and Revenue Forecasts

The financial prospects for QTERNMET XR depend on multiple intertwined factors:

• Market Penetration Rate: As of 2023, initial uptake remains modest, partly due to predilection for single-agent therapies and ongoing competition. However, with favorable clinical data and strategic payer negotiations,market penetration is projected to increase by a compound annual growth rate (CAGR) of approximately 8-12% over five years [3].

• Pricing Dynamics: The drug is positioned at a premium but justified by clinical benefits. Price increases, as seen with other diabetes medications, are expected to facilitate revenue growth, especially if coupled with expanded indications.

• Market Share Growth: Eli Lilly anticipates capturing a significant share of the fixed-dose combination segment, targeting shifts away from poly-pill regimens. Realistically, a 10-15% market share within its indicated population could translate into annual revenues ranging from $500 million to over $1 billion globally by 2025 [4].

• Pipeline and Lifecycle Management: Potential line extensions, such as combinations with other antidiabetics or label expansions for cardiovascular indications, can enhance revenue streams. Conversely, patent expiries or biosimilar entries could compress margins.

Forecasting Considerations

• Global Diabetes Trends: With the ascending global burden, especially in emerging markets, the demand for effective oral therapies like QTERNMET XR is poised to grow.

• Pricing and Reimbursement Policies: Countries with evolving healthcare systems may influence pricing strategies, affecting revenue trajectories.

• Market Competition and Innovation: Emergence of novel antidiabetic agents and biosimilars could pressure market share.

• Regulatory Approvals: Additional indications in cardiovascular or renal protection could catalyze sales, whereas delays or setbacks could hinder growth.

Strategic Implications

Eli Lilly’s focus on demonstrating cardiovascular value and expanding access in underserved markets will be critical. Maintaining a competitive edge requires continuous pharmacovigilance, strategic collaborations, and adaptive pricing models.

Key Takeaways

• QTERNMET XR is positioned at the intersection of burgeoning global diabetes management needs and the expanding portfolio of SGLT2 inhibitors.

• Its success hinges on gaining prescriber trust, favorable reimbursement, and expanding indications, especially in markets with high diabetes prevalence.

• Revenue growth forecasts project a steady CAGR of approximately 8-12% over five years, driven by increasing adoption, geographic expansion, and pipeline enhancements.

• Competitive pressures, patent protections, and healthcare policies will shape its financial trajectory, requiring nimble strategic responses.

• Collaboration with payers and clinicians is paramount to facilitate market penetration and maximize its commercial potential.

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FAQs

1. How does QTERNMET XR differentiate itself from other SGLT2 inhibitor combinations?
QTERNMET XR combines dapagliflozin with metformin XR in a single daily dose, offering convenience and demonstrating superior cardiovascular benefits, which differentiates it from other combinations with different SGLT2 inhibitors or dosing schedules.

2. What are the primary market barriers for QTERNMET XR?
Barriers include competition from established monotherapies and other fixed-dose combinations, safety concerns related to SGLT2 inhibitors, high drug costs, and limited formulary coverage in certain regions.

3. How significant is the global market for QTERNMET XR’s growth?
The expanding prevalence of T2DM worldwide, especially in Asia and Latin America, makes the global market highly promising, with potential for significant growth as access improves and indications expand.

4. What role do cardiovascular outcomes trials play in QTERNMET XR’s adoption?
Positive cardiovascular outcomes from dapagliflozin elevate the drug’s profile, increasing prescriber confidence and encouraging formulary inclusion, thereby driving sales.

5. Are there upcoming regulatory or pipeline developments that could influence QTERNMET XR’s market prospects?
Potential label expansions to include cardiovascular and renal indications, alongside ongoing safety evaluations, could further enhance its commercial appeal, contingent upon regulatory approvals.

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Sources

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2021.
[2] DAPA-CKD Trial: Heerspink et al., The New England Journal of Medicine, 2020.
[3] MarketResearch.com. Diabetes therapeutics market forecast, 2023-2028.
[4] Eli Lilly Annual Reports, 2022.