dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride - Profile

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What are the generic sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

International Patents:	292
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Constraining patent/regulatory exclusivity:

9,616,028*PED

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 dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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	210874-001	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	6,515,117*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
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No	8,501,698*PED				Y

Expired US Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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	210874-002	May 2, 2019	6,414,126
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	210874-003	May 2, 2019	9,198,925
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	6,414,126
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	9,198,925

International Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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
Australia	2003237886	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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
2139494	SPC/GB20/028	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719
2139494	34/2020	Austria		PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
2139494	2090034-6	Sweden		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE; REG. NO/DATE: EU/1/16/1108 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

Last updated: February 3, 2026

Investment Scenario and Fundamentals Analysis for Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride

Market Overview

The combination of dapagliflozin, metformin hydrochloride, and saxagliptin hydrochloride targets type 2 diabetes mellitus (T2DM), one of the most prevalent chronic conditions globally. The global T2DM drug market was valued at approximately $70 billion in 2022, with a projected compound annual growth rate (CAGR) of 6% through 2028.[1]

Product Profile and Competitive Position

• Dapagliflozin: An SGLT2 inhibitor developed by AstraZeneca, it gained approval for multiple indications, including T2DM and heart failure. It faces competition from other SGLT2 inhibitors like canagliflozin and empagliflozin.
• Metformin Hydrochloride: The first-line treatment in T2DM. Its patent expired in many jurisdictions, leading to widespread generics and low pricing pressure.
• Saxagliptin Hydrochloride: A DPP-4 inhibitor by Bristol-Myers Squibb and AstraZeneca. It competes with sitagliptin and linagliptin.

Investment Opportunities

1. Market Penetration and Growth

   The three-drug combination aims to improve glycemic control by targeting multiple pathways. Its potential lies in increasing adherence and optimizing treatment. Currently, combination drugs account for upwards of 30% of T2DM prescriptions globally, with growth driven by clinical efficacy and ease of use.[2]

2. Regulatory Approvals and Patent Exclusivity

   • Dapagliflozin’s patent extends until 2025–2028, with biosimilar versions expected thereafter.
   • SGLT2 inhibitors' expanding indication portfolio enhances longer-term revenue streams.
   • Regulatory approvals for combination formulations in key markets like the US, EU, and China are critical.

3. Pipeline and Development

   The combination is under investigation in multiple clinical trials, including cardiovascular and renal outcomes studies (e.g., DECLARE-TIMI 58 for dapagliflozin). Positive results can expand labeling and market size.

4. Pricing and Reimbursement Dynamics

   • Generics of metformin and saxagliptin reduce costs, but branded formulations or combination drugs often command premium pricing.
   • Payer policies favor drugs with demonstrated benefits in heart failure and renal disease, areas where dapagliflozin has shown promise.

Risks and Challenges

• Patent Cliff: Dapagliflozin faces generic competition starting around 2025, pressuring margins.
• Market Saturation: Heavy competition from existing SGLT2 and DPP-4 inhibitors limits market growth.
• Regulatory Risks: Future label expansions may encounter hurdles or delays.
• Pricing Pressures: Government initiatives to control healthcare costs, especially in emerging markets, could restrain pricing.

Financial Perspective

Parameter	Estimated Data
Global T2DM drug market in 2022	$70 billion
CAGR (2022–2028)	6%
Dapagliflozin peak sales (2022–2025)	Approx. $4 billion (est.)
Market share for SGLT2 inhibitors (2022)	25% of T2DM drugs
Pricing for combination drugs	Premium of 10–20% over generics

Strategic Recommendations

• Focus on markets with higher adoption of SGLT2 inhibitors, including North America and Europe.
• Leverage positive data on cardiovascular and renal benefits to expand indications.
• Monitor patent expiry timelines closely and develop strategies for biosimilar entry.
• Invest in clinical trials for broader indications to sustain growth post-patent expiry.

Conclusion

The combination of dapagliflozin, metformin hydrochloride, and saxagliptin hydrochloride offers an attractive opportunity within the expanding T2DM treatment space. Growth hinges on clinical data, regulatory approvals, and competitive positioning, especially as patent protections wind down. Investors should weigh high-end market potential against competitive and patent-maturity risks.

Key Takeaways

• The T2DM drug market is growing steadily, with combination therapies capturing increasing market share.
• Dapagliflozin's expanding indications, especially in cardiovascular and renal disease, bolster its long-term outlook.
• Patent expiries in the mid-2020s pose significant near-term risks, requiring strategic planning.
• Competitive pressure from generics and biosimilars will influence margins.
• Clinical trial progress remains crucial for market expansion.

FAQs

1. When does dapagliflozin patent expiry likely occur?
Patents expire between 2025 and 2028 in key markets, leading to biosimilar competition shortly thereafter.

2. Which markets present the most growth opportunities?
North America and Europe lead in adoption, followed by emerging markets with expanding healthcare access and T2DM prevalence.

3. How does combination therapy impact treatment adherence?
Combination therapies simplify regimens, improving adherence, which can translate into better market penetration.

4. What are the main competitive advantages of dapagliflozin?
Its demonstrated benefits in cardiovascular and renal outcomes, alongside a broad labeling portfolio, strengthen its market position.

5. What factors could influence the success of this drug combination?
Regulatory approvals, clinical trial outcomes, pricing policies, and patent protections are the primary determinants.

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References

[1] MarketResearch.com, "Global Diabetes Drugs Market," 2022.
[2] IQVIA, "Prescription Trends and Market Share Data," 2022.