QTERNMET XR Drug Patent Profile

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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.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There is one drug master file entry 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 thirty 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

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	9,616,028*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
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

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	210874-004	May 2, 2019	6,936,590
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019	6,414,126
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	210874-003	May 2, 2019	6,936,590

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
Argentina	026024	COMPUESTOS INHIBIDORES SGLT2 DE GLUCOSIDOS DE C-ARILO Y METODO, LAS COMPOSICIONES FARAMCEUTICAS QUE LOS CONTIENEN Y LOS INTERMEDIARIOS DE SINTESIS DEDICHOS COMPUESTOS
Argentina	040032	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO
Austria	295848
Austria	353334

Supplementary Protection Certificates for QTERNMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C300585	Netherlands		PRODUCT NAME: DAPAGLIFLOZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	PA2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	122013000033	Germany		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012

QTERNMET XR Market Dynamics, Patent Exposure, and Financial Trajectory

Last updated: November 8, 2026

Qternmet XR is AstraZeneca’s fixed-dose combination of dapagliflozin, saxagliptin, and extended-release metformin for adults with type 2 diabetes. The product received FDA approval in May 2019 but occupies a narrow commercial position relative to AstraZeneca’s Farxiga franchise and competing SGLT2, DPP-4, and GLP-1 products. AstraZeneca does not separately report Qternmet XR revenue, prescription volume, or profitability. Its financial trajectory is therefore best assessed through the performance of the underlying diabetes franchise, formulary dynamics, and generic exposure for each active ingredient.

What is Qternmet XR and how does it work?

Qternmet XR combines three established diabetes mechanisms in one extended-release tablet:

Component	Drug class	Primary role
Dapagliflozin	SGLT2 inhibitor	Increases urinary glucose excretion; also provides cardiovascular and renal outcome benefits through the broader dapagliflozin evidence base
Saxagliptin	DPP-4 inhibitor	Enhances glucose-dependent insulin secretion and suppresses glucagon
Metformin extended release	Biguanide	Reduces hepatic glucose production and improves insulin sensitivity

The FDA-approved strengths are based on dapagliflozin 5 mg or 10 mg, saxagliptin 5 mg, and metformin extended-release 1,000 mg or 2,000 mg daily. The product is used with diet and exercise in adults whose glycemic control is inadequate on metformin or who already require the three component medicines. It is not indicated for type 1 diabetes. The FDA label also contains warnings relating to ketoacidosis, volume depletion, genital mycotic infections, lactic acidosis, pancreatitis, heart failure risk associated with saxagliptin, and renal limitations.[1]

Qternmet XR differs from Qtern, which contains dapagliflozin and saxagliptin but does not contain metformin. It also differs from Xigduo XR, which combines dapagliflozin and metformin without saxagliptin.

When did Qternmet XR receive FDA approval?

The FDA approved Qternmet XR in May 2019 under New Drug Application 210110. The approval followed earlier U.S. approvals for the individual agents and for the two-drug combination Qtern.[1]

Milestone	Date
Dapagliflozin U.S. approval	2014
Saxagliptin U.S. approval	2009
Qtern U.S. approval	2017
Qternmet XR U.S. approval	May 2019
Primary commercial setting	Type 2 diabetes
Regulatory pathway	New drug application for a fixed-dose combination

The approval timing was commercially unfavorable. By 2019, physicians and payers already had access to separate dapagliflozin, saxagliptin, and metformin products, as well as competing fixed-dose combinations. The product therefore entered a market where convenience was its main differentiator rather than novel pharmacology.

How large is the Qternmet XR market?

Qternmet XR is a niche product rather than a separately material revenue contributor for AstraZeneca. The company reports Farxiga revenue as part of its cardiovascular, renal, and metabolic portfolio, but does not break out Qternmet XR or Qtern revenue in its annual reports.[2]

The principal commercial value sits in dapagliflozin, not in the Qternmet XR brand.

AstraZeneca’s diabetes franchise

Farxiga has become one of AstraZeneca’s largest products because its use expanded beyond glycemic control into heart failure and chronic kidney disease. Those broader indications have materially increased the value of dapagliflozin. Qternmet XR does not capture the full benefit of that expansion because its approved positioning is primarily diabetes treatment and because the combination contains saxagliptin, which is associated with a heart-failure warning in the FDA label.[1]

AstraZeneca reported Farxiga sales of approximately $5.5 billion in 2023, making the product a major growth driver for the company.[2] Qternmet XR sales are not separately disclosed and are likely immaterial relative to Farxiga. The product’s contribution is more likely to be reflected in broader diabetes-product reporting or bundled commercial activity than in a distinct revenue line.

What are the main market dynamics affecting Qternmet XR?

SGLT2 growth supports dapagliflozin but not necessarily Qternmet XR

Dapagliflozin benefits from clinical adoption in heart failure and chronic kidney disease. Those indications have expanded prescriber awareness and payer focus on the molecule. Qternmet XR gains indirect recognition from that growth, but the combination does not automatically inherit all of Farxiga’s cardiovascular and renal commercial momentum.

The product is constrained by its inclusion of saxagliptin. DPP-4 inhibitors remain widely used, but their growth is weaker than that of SGLT2 inhibitors and GLP-1 receptor agonists. Saxagliptin also competes with sitagliptin, linagliptin, and generic DPP-4 options.

Fixed-dose convenience has limited economic power

Qternmet XR reduces pill burden for patients who need all three ingredients. That advantage can support adherence and physician convenience. Payers, however, frequently prefer lower-cost generic metformin plus a preferred SGLT2 inhibitor or DPP-4 inhibitor prescribed separately.

A fixed-dose combination can also create formulary problems if a payer covers one component but not the full combination. Physicians may then prescribe separate tablets to preserve access or reduce patient cost.

GLP-1 competition weakens the category

GLP-1 receptor agonists and dual incretin products have changed treatment sequencing for patients requiring substantial glucose lowering or weight reduction. Products such as semaglutide and tirzepatide compete for patients who might otherwise receive escalating oral therapy.

Qternmet XR remains relevant for patients who prefer oral treatment, cannot tolerate injectable therapy, or require a multi-agent regimen without a GLP-1 product. Its growth ceiling is lower because weight loss is not a central value proposition.

How does Qternmet XR compare with competing diabetes drugs?

Product	Active ingredients	Strategic position
Qternmet XR	Dapagliflozin, saxagliptin, metformin ER	Triple oral therapy with SGLT2 and DPP-4 mechanisms
Qtern	Dapagliflozin, saxagliptin	Dual oral therapy without metformin
Xigduo XR	Dapagliflozin, metformin ER	Directly aligned with the dapagliflozin-plus-metformin need
Janumet XR	Sitagliptin, metformin ER	Established DPP-4 combination competitor
Synjardy XR	Empagliflozin, metformin ER	SGLT2-plus-metformin competitor from Boehringer Ingelheim and Eli Lilly
Trijardy XR	Empagliflozin, linagliptin, metformin ER	Closest major triple-combination competitor
GLP-1 products	Semaglutide, tirzepatide and others	Higher-value alternatives for weight and glucose control

Trijardy XR is the most direct branded comparison because it also provides triple oral therapy. Its SGLT2 component is empagliflozin, while its DPP-4 component is linagliptin. The broader SGLT2 class has strong clinical demand, but brand-level competition depends on formulary preference, rebates, renal labeling, and negotiated net price.

What patents protect Qternmet XR?

Qternmet XR has several potential layers of intellectual-property protection:

1. Patents covering dapagliflozin.
2. Patents covering saxagliptin.
3. Patents covering extended-release metformin technology.
4. Patents covering the fixed-dose combination, formulation, or manufacturing process.
5. Regulatory exclusivity associated with the approved combination product.

The commercial significance of these layers differs. Component patents do not necessarily prevent a generic manufacturer from marketing the other components separately. A combination patent can be more relevant to an ANDA directed to the exact Qternmet XR formulation, while formulation and process patents may be challenged or designed around.

The FDA Orange Book is the controlling public source for patent listings associated with approved products. Qternmet XR’s patent position must be evaluated separately from Farxiga’s broader dapagliflozin patent estate and from patents covering Qtern. AstraZeneca’s protection for dapagliflozin as a molecule does not necessarily provide equivalent protection for the full Qternmet XR product.[3]

When does Qternmet XR lose exclusivity?

Qternmet XR does not have a single commercially decisive expiry date. Its exclusivity profile depends on the patent claims asserted against a generic product and on whether an ANDA applicant challenges the listed patents under Paragraph IV.

The most important distinction is between:

• The expiration of dapagliflozin patents.
• The expiration of saxagliptin patents.
• The expiration of combination and formulation patents.
• The date on which a generic applicant can obtain approval.
• The date on which a generic applicant can commercially launch.

Dapagliflozin and saxagliptin are small molecules, so Qternmet XR faces generic rather than biosimilar risk. Metformin has long been generic. Once a viable ANDA is approved and litigation barriers are resolved, generic substitution can materially reduce net price.

Publicly reported AstraZeneca filings identify Farxiga as a major product exposed to eventual generic competition, but they do not provide a separate Qternmet XR revenue forecast or a product-specific loss-of-exclusivity forecast.[2] No prominent Qternmet XR-specific Paragraph IV litigation materially affecting the product’s reported financial trajectory is identified in the cited public sources.

What is the Orange Book status of Qternmet XR?

Qternmet XR is an FDA-approved prescription drug listed in the FDA’s Orange Book framework. Orange Book analysis should distinguish the NDA from the separate NDAs for Qtern, Farxiga, Onglyza, and metformin products.[3]

The practical questions for generic entry are:

• Whether Qternmet XR has active listed patents.
• Whether those patents cover the full strength and dosage form.
• Whether an ANDA applicant submits a Paragraph IV certification.
• Whether AstraZeneca files infringement litigation within the statutory period.
• Whether a settlement permits an earlier generic launch.

A generic manufacturer may also pursue a product that substitutes the individual components rather than replicating the branded fixed-dose tablet. That approach can erode Qternmet XR demand even before a fully substitutable three-drug generic becomes available.

Which companies are competing with or challenging Qternmet XR?

The main competitive pressure comes from manufacturers with products in adjacent combinations rather than from a single direct challenger.

• Boehringer Ingelheim and Eli Lilly compete through Jardiance, Synjardy XR, and Trijardy XR.
• Merck and its partners compete through Januvia and Janumet XR.
• Novo Nordisk competes through GLP-1 products, including semaglutide.
• Eli Lilly competes through tirzepatide.
• Generic manufacturers compete through dapagliflozin, saxagliptin, metformin, and separate-tablet regimens as patents and regulatory barriers expire.

The competitive threat is therefore broader than a Qternmet XR-specific ANDA. Prescribers can bypass the product through therapeutic substitution, formulary-driven switching, or use of component medicines.

What is the financial trajectory for Qternmet XR?

Qternmet XR’s financial trajectory is likely characterized by initial launch uptake, limited scale, and eventual price pressure rather than sustained high growth.

Period	Financial interpretation
2019-2020	Launch phase with limited differentiation and established component competition
2021-2023	Indirect benefit from growing dapagliflozin awareness, offset by strong competition and limited standalone reporting
2024 onward	Greater exposure to generic component pricing, formulary pressure, and substitution by GLP-1 or other SGLT2 regimens
Long term	Low strategic importance as a standalone product compared with Farxiga

The main value driver is AstraZeneca’s dapagliflozin franchise. Qternmet XR is unlikely to be a meaningful independent contributor to group revenue because its sales are not reported separately and because the product competes against lower-cost component therapy.

Its residual value may persist in markets where fixed-dose combinations are preferred, adherence is a concern, or reimbursement favors a single prescription. Those factors can support a small but durable base of demand. They are unlikely to offset broad generic erosion once relevant combination or component protections lapse.

How strong is the Qternmet XR patent estate?

The estate is commercially moderate rather than highly defensive.

Its strengths are the complexity of a triple fixed-dose formulation and the possibility that generic applicants must address multiple active ingredients and formulation claims. Its weaknesses are the availability of all three components from established generic sources, the ability of physicians to prescribe separate tablets, and the absence of a novel active pharmaceutical ingredient.

The product’s strongest asset is commercial association with dapagliflozin. Its weakest asset is the lack of a unique mechanism or indication that cannot be replicated through separate products.

Key Takeaways

• Qternmet XR is AstraZeneca’s triple oral combination of dapagliflozin, saxagliptin, and metformin ER.
• FDA approval occurred in May 2019.
• AstraZeneca does not separately disclose Qternmet XR revenue, prescriptions, or profitability.
• Farxiga’s cardiovascular and renal growth supports dapagliflozin demand but does not translate directly into equivalent Qternmet XR growth.
• The product competes with Trijardy XR, Synjardy XR, Janumet XR, separate-tablet regimens, and GLP-1 therapies.
• Generic risk is more important than biosimilar risk because all three ingredients are small molecules.
• Patent analysis must separate Qternmet XR combination claims from the broader Farxiga and saxagliptin estates.
• The likely commercial trajectory is niche persistence followed by increasing price and substitution pressure.

FAQs

Is Qternmet XR the same as Qtern?

No. Qtern contains dapagliflozin and saxagliptin. Qternmet XR adds extended-release metformin.

Does Qternmet XR provide the same heart-failure benefit as Farxiga?

The product contains dapagliflozin, but Qternmet XR should not be treated as interchangeable with Farxiga for every cardiovascular or renal indication. Approved indications and labeling must be evaluated product by product.

Is Qternmet XR exposed to biosimilar competition?

No. Dapagliflozin, saxagliptin, and metformin are small-molecule drugs. The relevant threat is generic competition through ANDAs and separate-tablet substitution.

What is the closest branded competitor to Qternmet XR?

Trijardy XR is the closest major branded triple oral competitor because it combines an SGLT2 inhibitor, a DPP-4 inhibitor, and metformin ER.

Is Qternmet XR financially material to AstraZeneca?

AstraZeneca does not report Qternmet XR separately. The product is not identified as a material standalone revenue driver in the company’s public financial reporting. Its economic relevance is substantially lower than that of Farxiga.

References

1. U.S. Food and Drug Administration. (2019). Qternmet XR prescribing information.
2. AstraZeneca PLC. (2024). Annual report and Form 20-F 2023.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.