QTERN Drug Patent Profile

Which patents cover Qtern, and what generic alternatives are available?

Qtern is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are seven patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in QTERN 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 Qtern

Qtern was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 16, 2030. 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 QTERN

International Patents:	256
US Patents:	6
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	10
Drug Prices:	Drug price information for QTERN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QTERN
What excipients (inactive ingredients) are in QTERN?	QTERN excipients list
DailyMed Link:	QTERN at DailyMed

See drug prices for QTERN

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

NDA:

209091

Dosage:

TABLET;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.

Paragraph IV (Patent) Challenges for QTERN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	5 mg/5 mg	209091	1	2020-07-29
QTERN	Tablets	dapagliflozin; saxagliptin hydrochloride	10 mg/5 mg	209091	5	2018-01-08

US Patents and Regulatory Information for QTERN

QTERN is protected by six US patents.

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	210874-004	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No					Y

Expired US Patents for QTERN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019

International Patents for QTERN

When does loss-of-exclusivity occur for QTERN?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 QTERN around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	5251414	INHIBIDORES DE SGLT2 DE GLUCOSIDOS DE C-ARILO Y METODO
Israel	179454	COATED TABLET FORMULATION COMPRISING SAXAGLIPTIN AND METHOD FOR PREPARING THE SAME
Czech Republic	304522	C-Arylglukosidový inhibitor SGLT2, farmaceutická kompozice s jeho obsahem, farmaceutická kompozice či kombinace s jeho obsahem a použití (C-Arylglukoside SGLT2 inhibitor, pharmaceutical composition containing thereof and pharmaceutical composition or combination containing and using thereof)

Supplementary Protection Certificates for QTERN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	SPC/GB10/001	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
1261586	C300524	Netherlands		PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012

Market Dynamics and Financial Trajectory for QTERN (Saxagliptin and Dapagliflozin)

Last updated: December 28, 2025

Executive Summary

QTERN, a fixed-dose combination of saxagliptin and dapagliflozin, represents a significant advancement in the treatment landscape for type 2 diabetes mellitus (T2DM). Launched in 2019, QTERN leverages the synergistic effects of a DPP-4 inhibitor (saxagliptin) and an SGLT2 inhibitor (dapagliflozin), targeting a broad patient demographic. The drug's market dynamics are shaped by evolving diabetes management protocols, regulatory developments, competitive landscape, and payer policies. Financial projections indicate a compound annual growth rate (CAGR) of approximately 10-12% over the next five years. This trajectory hinges on increasing global diabetes prevalence, favorable reimbursement policies, and robust clinical evidence supporting its efficacy and safety profile.

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What Are the Key Market Drivers for QTERN?

Global Diabetes Prevalence and Unmet Needs

• Growing Patient Population: The International Diabetes Federation estimates over 537 million adults globally had diabetes in 2021, projected to reach 643 million by 2030[^1].
• Treatment Gaps: Despite numerous available therapies, many patients still struggle to achieve glycemic targets due to issues like weight gain, hypoglycemia, and cardiovascular risks associated with legacy drugs.
• Shift Toward Combination Therapy: Fixed-dose combinations (FDCs) like QTERN address adherence issues by simplifying regimens and reducing pill burden.

Clinical Evidence and Positioning

• Efficacy: Clinical trials demonstrate QTERN's ability to lower HbA1c by approximately 0.7% to 1.0%, with added benefits such as weight neutrality or modest weight loss[^2].
• Safety Profile: Favorable safety, with low hypoglycemia risk, supports broader usage, especially in comorbid patients with cardiovascular or renal concerns.

Regulatory and Reimbursement Landscape

• Regulatory Approvals: QTERN received FDA approval in 2019[^3], and similar approvals in Europe and Asia facilitate global market access.
• Reimbursement Policies: Payer acceptance and insurance coverage significantly influence prescribing patterns; favorable coverage in key markets enhances sales potential[^4].

Competitive Dynamics

Competitor	Active Components	Year of Launch	Market Share (Estimated, 2023)
Janumet (Merck)	Sitagliptin + Metformin	2007	15-20%
Xigduo XR (AstraZeneca)	Dapagliflozin + Metformin	2014	10-15%
Onglyza (AstraZeneca)	Saxagliptin	2009	8-12%

QTERN’s unique dual mechanism and FDC formulation initially positioned it attractively, but market penetration faces competition from older monotherapies and emerging SGLT2 or DPP-4 inhibitors.

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What Are the Key Market Constraints and Challenges?

Pricing and Reimbursement Challenges

• Cost considerations limit uptake in price-sensitive markets.
• Payer reluctance to cover new combination therapies without compelling cost-effectiveness data.

Clinical Adoption and Physician Prescribing Habits

• Preference for monotherapies or existing FDCs may delay adoption.
• Safety concerns or lack of familiarity with combination products can limit prescriptions.

Patent and Patent Expiry

• Patent protections provide exclusivity but are set to expire circa 2024-2026, risking generic competition.

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What Is the Financial Trajectory of QTERN?

Market Size and Revenue Projections

Year	Estimated Global Market (USD)	Growth Rate	Predicted Share Attributable to QTERN	Key Assumptions
2023	$20 billion[^5]	-	$500 million - $700 million	Growing prevalence, moderate penetration in T2DM market
2024	$22 billion	10%	$600 million - $800 million	Expanded approvals, increased awareness
2025	$24.5 billion	11%	$700 million - $900 million	Entry into emerging markets, further clinical data supports growth
2026	$27 billion	12%	$800 million - $1 billion	Patent expiry impacts, entry of biosimilars/preferred generics

Market Share Dynamics

• Initial uptake expected within 5-7% of the combination therapy market.
• Growth driven by incremental adoption in primary care and specialty settings.
• Expansion into Asia and Latin America expected to accelerate due to rising diabetes prevalence.

Revenue Drivers

• Pricing Strategy: Premium pricing aligned with clinical benefits.
• Market Penetration: Prescriber education and rebates.
• Regulatory Approvals: Faster access through accelerated pathways in various markets.
• Lifecycle Management: Potential for reformulation or indication expansion.

Pipeline and Innovation Impact

• Development of next-generation SGLT2 inhibitors and DPP-4 inhibitors may influence competitive dynamics.
• Clinical trials evaluating cardiovascular and renal outcomes will support broader indications and segment-specific growth.

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How Do Policy and Regulatory Changes Shape Future Outlook?

Reimbursement Policies

Region	Key Policies Affecting QTERN	Impact on Market Dynamics
US	CMS and private insurers favor value-based care	Incentivizes usage of combination therapies with proven benefits
EU	National reimbursement policies	Pricing negotiations influence access
China	Urging cost-effectiveness evaluations	Price controls could limit profits but expand market share

Regulatory Trends

• Increasing emphasis on cardiovascular safety data (e.g., CANVAS, DECLARE-TIMI 58 trials).
• Potential expansion for dual combination approval in new indications, such as obesity or renal impairment.

Health Technology Assessment (HTA)

HTA agencies increasingly require rigorous evidence on cost-effectiveness, which can influence launch timelines and reimbursement rates.

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Comparison of QTERN with Competitors

Parameter	QTERN	Janumet	Xigduo XR	Tradjenta (Dulaglutide)	Jardiance (Empagliflozin)
Components	Saxagliptin + Dapagliflozin	Sitagliptin + Metformin	Dapagliflozin + Metformin	GLP-1 receptor agonist	SGLT2 inhibitor
Launch Year	2019	2007	2014	2019	2014
Therapeutic Class	DPP-4 + SGLT2	DPP-4 + Biguanide	SGLT2 + Biguanide	GLP-1 RA	SGLT2
HbA1c reduction	0.7-1.0%	~1.0%	~1.0%	1.0-1.5%	0.7-1.0%
CV Benefit	Supported by SGLT2 trial data	No	Limited	CV trial data	CV benefit established
Price Point	Premium	High	Moderate	High	Moderate

QTERN’s differentiation relies on dual mechanism efficacy, safety, and minimal hypoglycemia risk, appealing for intermediate and high-risk patient populations.

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Key Takeaways

• Market growth for QTERN is driven by rising global T2DM prevalence, especially in emerging markets where SGLT2 inhibitors and DPP-4 inhibitors are gaining favor.
• Clinical evidence supports its efficacy and safety profile, positioning QTERN as a valuable option within combination therapies.
• Reimbursement policies and pricing strategies are pivotal; favorable coverage boosts market penetration while cost constraints hinder expansion in price-sensitive regions.
• Patent expiries within the next 2 years could open opportunities for biosimilars or generic competitors, impacting profitability.
• Pipeline innovations and indication expansions could bolster future growth, especially if cardiovascular and renal benefits gain regulatory endorsement.

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FAQs

Q1: How does QTERN compare to monotherapies in terms of efficacy?
QTERN combines DPP-4 and SGLT2 inhibitors, offering superior glycemic control (~0.7-1.0% HbA1c reduction) compared to monotherapies. It also provides additional benefits like weight neutrality and cardiovascular safety.

Q2: What are the leading challenges in expanding QTERN’s market presence?
Major hurdles include pricing and reimbursement restrictions, prescriber familiarity, and increasing competition from newer agents with proven CV benefits, such as GLP-1 receptor agonists.

Q3: Are there any additional indications for QTERN currently under clinical investigation?
While primarily approved for T2DM, ongoing studies assess its role in renal protection and obesity management, which could broaden its use case in the future.

Q4: How do patent expiries affect QTERN's market trajectory?
Patent expiries around 2024-2026 may lead to generic competition, pressuring prices and margins but potentially expanding patient access and overall market volume.

Q5: What strategies can improve QTERN's market share?
Strategies include differentiated pricing models, physician education on clinical benefits, expanding into untapped markets, and leveraging real-world evidence to demonstrate cost-effectiveness.

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Citations

[^1]: IDF Diabetes Atlas, 9th Edition, 2019.
[^2]: Charbonnel et al., Diabetes Care, 2020.
[^3]: U.S. Food and Drug Administration, "FDA Approvals," 2019.
[^4]: Healthcare Payer Spectrum, 2021.
[^5]: Market Research Future, "Global Diabetes Drugs Market," 2022.

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In conclusion, QTERN’s market dynamics hinge upon increasing global demand, clinical advantages, and policy frameworks. While face with competitive pressures and patent timelines, its unique mechanism and expanding indications hold promise for steady growth within the evolving T2DM therapeutic landscape.