QTERN Drug Patent Profile

Which patents cover Qtern, and when can generic versions of Qtern launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QTERN

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
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No					Y

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
Portugal	1261586
Poland	2508188
Israel	151372
Taiwan	I354569
China	100534997
Russian Federation	2002109477	С-арилглюкозидные ингибиторы SGTL2

Supplementary Protection Certificates for QTERN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211	132014902277722	Italy		PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211	C20140021 00131	Estonia		PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211	1390017-0	Sweden		PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124

QTERN Investment Scenario and Fundamentals Analysis

Last updated: February 8, 2026

Summary QTERN (dapagliflozin + saxagliptin) is a combination therapy approved for type 2 diabetes mellitus (T2DM). As of 2023, it occupies a competitive niche, with strategic implications driven by market penetration, patent status, and pipeline developments. The analysis covers market positioning, financial performance, regulatory landscape, and future growth potential.

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What is the current market positioning of QTERN?

QTERN, marketed by AstraZeneca, combines dapagliflozin (SGLT2 inhibitor) and saxagliptin (DPP-4 inhibitor). Approved by the FDA in 2019, it targets patients inadequately controlled on monotherapy or dual therapy. The drug faces competition from standalone SGLT2 inhibitors (e.g., Jardiance, Invokana), DPP-4 inhibitors (e.g., Januvia), and other fixed-dose combinations like Glucovance (metformin + glyburide).

Market share estimates for QTERN:

Parameter	2023 Figures
Estimated global sales	~$350 million (projected)
Market penetration in U.S.	3-4% among T2DM combo therapies
Competitor sales (e.g., Jardiance)	$3 billion annually (Eli Lilly/Boehringer)

The drug's sales remain modest due to limited prescribing adoption and generic competition for individual components.

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What are the key revenue drivers and barriers?

Revenue Drivers

• Increasing prevalence of T2DM globally, reaching an estimated 537 million in 2023 (IDF)[1].
• Growing adoption of combination therapies for better glycemic control.
• Regulatory expansions: approvals in multiple markets enhance access.

Barriers

• Patent expiration for saxagliptin (original patent expired in 2022), with formulation-specific patents possibly expiring by 2025.
• Generic/EPA competition for individual components diminishes pricing power.
• Prescribing trends favor SGLT2 inhibitors with proven cardiovascular and renal benefits.

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What are the fundamentals of QTERN’s financial performance?

Revenue Trends

Year	Estimated Revenue	Notes
2020	~$250 million	Launch phase
2021	~$300 million	Steady growth; increased prescriptions
2022	~$330 million	Market saturation begins
2023	~$350 million	Market growth slowdowns, patent expiry concerns

Cost Structure

• Production costs mirror those of component drugs, with marginal additional costs for the fixed-dose formulation.
• Marketing expenses focus on endocrinologists and primary care physicians.

Profitability

• Margins remain pressures from the entry of generics.
• Estimated gross margin around 60%, with net margins likely below 20% due to promotional expenses and patent cliffs.

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What is the regulatory landscape affecting QTERN?

• Approved in the U.S., EU, Japan, and Canada.
• Patent protection for core components expires sequentially from 2022-2025.
• Potential approval in emerging markets can extend access, but pricing and reimbursement are variable.

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What is the future growth potential?

Pipeline and Strategic Initiatives

• AstraZeneca's focus on expanding SGLT2 inhibitor portfolio and cardiovascular indications.
• Development of next-generation fixed-dose combinations targeting broader diabetic populations.
• Potential expansion into obesity and NASH indications with dapagliflozin.

Market Dynamics

• The global diabetes therapeutics market is projected to grow at a CAGR of 7.3% through 2028[2].
• Increased emphasis on combination drugs for adherence drives demand.
• Competitive innovations include dual inhibitors and novel delivery mechanisms.

Risks

• Price erosion due to generic entries.
• Regulatory delays or rejections outside current markets.
• Preferential shift towards drugs with proven cardiovascular benefits.

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Key Takeaways

• QTERN's sales are stable but limited, impacted by patent expiries and competition.
• The drug benefits from growing T2DM prevalence but faces pricing pressures.
• AstraZeneca's pipeline investments could influence its long-term value.
• Competitive landscape favors drugs with additional indications and cardiovascular evidence.
• The future depends heavily on regulatory approvals, patent protection, and market acceptance.

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FAQs

1. How does QTERN compare with other combination therapies?
QTERN competes primarily with other dual therapy options, but drugs like Jardiance + Janumet offer similar or better efficacy with proven cardiovascular benefits. Cost and formulary preferences influence prescribing patterns.

2. What is the patent outlook for QTERN?
Key patents for saxagliptin expired in 2022, with formulation-specific patents extending into 2025. Generics are expected to enter the market soon, pressuring prices.

3. Are there upcoming regulatory decisions that could impact QTERN?
No major approvals or rejections are scheduled for 2023; future approvals in emerging markets could support growth.

4. What are the main investment risks?
Patent expiry, generic competition, shifting prescribing trends, and potential regulatory setbacks are critical risks.

5. What strategic moves can AstraZeneca make regarding QTERN?
Prioritizing label expansion into obesity and NASH indications, optimizing cost management, and strengthening cardiovascular evidence can support its positioning.

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Sources
[1] International Diabetes Federation. "IDF Diabetes Atlas," 2023.
[2] MarketsandMarkets. "Diabetes Therapeutics Market," 2023.