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-six 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 November 12, 2030. This may change due to patent challenges or generic licensing.

There have been nineteen 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:	346
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

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	6,515,117		Y	Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	9,616,028		Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	7,919,598			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	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	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
Czech Republic	304355	2-Azabicyklo[3.1.0.]hexan-3-karbonitrilová sloučenina, farmaceutický prostředek a použití (2-Azabicyclo [3.1.0]hexane-3-carbonitrile compound, pharmaceutical composition and use thereof)
Mexico	2008015377	SOLVATOS Y COMPLEJOS CRISTALINOS DE LOS DERIVADOS DE (1S) - 1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOACIDOS COMO INHIBIDORES DE SGLT2 PARA EL TRATAMIENTO DE LA DIABETES. (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES.)
Taiwan	I354569

Supplementary Protection Certificates for QTERNMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
2139494	LUC00176	Luxembourg		PRODUCT NAME: SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719

QTERNMET XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QTERNMET XR

Introduction

QTERNMET XR, a once-daily oral medication, is a significant addition to the treatment arsenal for type-2 diabetes. It combines the selective sodium-glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin, the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin, and metformin hydrochloride extended release. Here, we delve into the market dynamics and financial trajectory of QTERNMET XR.

Approval and Regulatory Landscape

QTERNMET XR was approved by the US Food and Drug Administration (FDA) in May 2019 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes[1][4].

Clinical Evidence and Efficacy

The approval was based on two Phase III trials that evaluated the combination of dapagliflozin and saxagliptin on a background of metformin. These trials demonstrated statistically significant decreases in HbA1c levels and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%[1].

Market Position and Competition

The diabetes treatment market is highly competitive, with numerous drugs and combinations available. However, QTERNMET XR's unique mechanism of action, combining three effective agents, sets it apart. The drug's clinical evidence and the synergistic effects of its components help maintain its market position[3].

Revenue Contribution

QTERNMET XR is part of AstraZeneca's growing diabetes franchise, which has seen significant revenue growth. For example, Farxiga (dapagliflozin), a key component of QTERNMET XR, saw revenues increase by 40% in the first half of 2023. This growth is indicative of the strong performance of QTERNMET XR in contributing to AstraZeneca's overall revenue[3].

Geographical Performance

United States

In the US, QTERNMET XR has been part of AstraZeneca's diabetes portfolio since its approval in 2019. The unique combination of dapagliflozin and metformin has helped the drug gain a significant market share in the US diabetes treatment market[3].

Emerging Markets

The approval of QTERNMET XR in emerging markets, particularly in China, is expected to drive significant growth. China's large and growing diabetes market, where type 2 diabetes accounts for more than 90% of the diabetes population, presents a substantial opportunity for the drug[3].

Financial Trajectory

Revenue Growth

AstraZeneca reported total revenue of $22,295 million in the first half of 2023, with a 16% increase excluding COVID-19 medicines. The strong performance in the cardiovascular, renal, and metabolism (CVRM) therapy area, where QTERNMET XR is categorized, has been a key driver of this growth[3].

Core EPS

The company's core earnings per share (EPS) increased by 21% to $4.07 in the first half of 2023, reflecting the positive impact of new launches and increased patient access to key medicines like QTERNMET XR[3].

Future Outlook

Growth Projections

AstraZeneca anticipates continued growth in its diabetes franchise, including QTERNMET XR. The company expects total revenue from China to return to growth and increase by a low-to-mid single-digit percentage in FY 2023, partly driven by the approval and launch of QTERNMET XR[3].

Market Expansion

The success of QTERNMET XR in new markets, combined with its established presence in existing markets, is expected to contribute to AstraZeneca's overall revenue growth. The drug's approval in regions like China and its first-line treatment status are crucial factors in this expansion[3].

Competitive and Regulatory Factors

Competition

The diabetes treatment market is highly competitive, with numerous drugs and combinations available. QTERNMET XR's unique mechanism and clinical evidence will be crucial in maintaining its market position against competitors[3].

Regulatory Environment

Continued regulatory approvals and favorable reimbursement policies will be essential for the long-term success of QTERNMET XR. The drug's approval process and subsequent regulatory environment will play a significant role in its market dynamics[3].

Key Takeaways

• Unique Combination: QTERNMET XR offers a unique combination of dapagliflozin, saxagliptin, and metformin, setting it apart in the diabetes treatment market.
• Global Approvals: The drug has been approved in several regions, including the US and China, expanding its market reach.
• Revenue Contribution: QTERNMET XR contributes to AstraZeneca's growing revenue in the diabetes segment.
• Future Growth: The drug is expected to drive growth in emerging markets, particularly in China, and maintain its market share in established markets.

Illustrative Statistics

• Revenue Increase: Farxiga (dapagliflozin), a key component of QTERNMET XR, saw revenues increase by 40% in the first half of 2023[3].
• Market Share: The unique combination of dapagliflozin and metformin has helped QTERNMET XR gain a significant market share in the US diabetes treatment market[3].
• Emerging Markets Growth: AstraZeneca saw a 28% increase in revenue in ex-China emerging markets in the first half of 2023, partly attributed to the expansion of its diabetes portfolio[3].

"QTERNMET XR is a once-daily, oral medicine compromised of the selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor saxagliptin and metformin hydrochloride extended release."[1]

Conclusion

QTERNMET XR has established itself as a significant player in the diabetes treatment market, driven by its unique combination of active ingredients and strong clinical evidence. The drug's approval in key markets and its contribution to AstraZeneca's revenue growth underscore its importance in the company's portfolio.

Key Takeaways

• Unique Mechanism: QTERNMET XR combines dapagliflozin, saxagliptin, and metformin, offering a synergistic approach to glycemic control.
• Global Approval: Approved in the US and China, among other regions, expanding its market reach.
• Revenue Growth: Contributes significantly to AstraZeneca's growing diabetes franchise.
• Future Outlook: Expected to drive growth in emerging markets and maintain market share in established markets.

FAQs

What is QTERNMET XR used for?

QTERNMET XR is used as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.

What are the active ingredients in QTERNMET XR?

The active ingredients are dapagliflozin (an SGLT-2 inhibitor), saxagliptin (a DPP-4 inhibitor), and metformin hydrochloride extended release.

When was QTERNMET XR approved by the FDA?

QTERNMET XR was approved by the FDA in May 2019.

How does QTERNMET XR contribute to AstraZeneca's revenue?

QTERNMET XR is part of AstraZeneca's growing diabetes franchise, contributing to the company's overall revenue growth, particularly in the CVRM therapy area.

What are the future growth projections for QTERNMET XR?

AstraZeneca expects QTERNMET XR to drive growth in emerging markets, particularly in China, and maintain its market share in established markets.

Sources

1. AstraZeneca Media Centre: "Qternmet XR approved in the US for the treatment of type-2 diabetes"[1].
2. Annual Reports: "AstraZeneca Annual Report 2020"[2].
3. Drug Patent Watch: "XIGDUO XR Drug Patent Profile"[3].
4. FDA Clinical Review: "Clinical Review(s) - QTERNMET XR"[4].
5. AstraZeneca Annual Report: "AstraZeneca Annual Report 2019"[5].