Dapagliflozin; metformin hydrochloride - Generic Drug Details

What are the generic drug sources for dapagliflozin; metformin hydrochloride and what is the scope of patent protection?

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and thirty-six patent family members in forty-six countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dapagliflozin; metformin hydrochloride

International Patents:	236
US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	123
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride
DailyMed Link:	dapagliflozin; metformin hydrochloride at DailyMed

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

Recent Clinical Trials for dapagliflozin; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AJU Pharm Co., Ltd.	PHASE1
Wuhan Central Hospital	PHASE4
Renmin Hospital of Wuhan University	PHASE4

See all dapagliflozin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dapagliflozin; metformin hydrochloride

Drug Class	Biguanide Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for dapagliflozin; metformin 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	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	8,685,934*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	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	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	6,515,117*PED				Y

Expired US Patents for dapagliflozin; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	9,198,925
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	6,936,590
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	6,414,126
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	6,936,590
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	6,414,126

International Patents for dapagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2007265246
Malaysia	142499	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD
Russian Federation	2008122558	ФАРМАЦЕВТИЧЕСКАЯ КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР SGLT2
Germany	60020259
Japan	2017160212	別の抗糖尿病薬を用いた先の治療に抵抗性を有する２型糖尿病患者をＳＧＬＴ２阻害剤およびその組成物を用いて治療する方法 (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS, EMPLOYING SGLT2 INHIBITOR AND COMPOSITIONS THEREOF)
Eurasian Patent Organization	028259
Norway	346828

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	C 2013 012	Romania		PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
2498758	2090013-0	Sweden		PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
2498758	CA 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1506211	18/2013	Austria		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112

Market Dynamics and Financial Trajectory for Dapagliflozin and Metformin Hydrochloride

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape for diabetic therapies has experienced significant evolution, driven by innovations in drug development, regulatory policies, and rising global diabetes prevalence. Among the key players, dapagliflozin and metformin hydrochloride stand out due to their proven efficacy and expansive market adoption. This article provides a comprehensive analysis of the market dynamics and the financial trajectory of these two drugs, emphasizing how their positions are shaping healthcare strategies and investment opportunities.

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Overview of Dapagliflozin and Metformin Hydrochloride

Dapagliflozin is an SGLT2 inhibitor developed by AstraZeneca, primarily indicated for type 2 diabetes mellitus (T2DM), with additional approvals for heart failure and chronic kidney disease (CKD). Its mechanism involves promoting glycosuria, thereby lowering blood glucose levels independently of insulin pathways, which offers advantages for patients with insulin resistance.

Metformin hydrochloride, developed in the 1950s and extensively adopted since then, remains the first-line oral antihyperglycemic agent globally. It operates by decreasing hepatic glucose production and improving insulin sensitivity. Its long-term safety profile and cost-effectiveness underpin its continued dominance in the management of T2DM.

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Market Dynamics

1. Global Diabetes Burden and Market Expansion

The global prevalence of T2DM has risen sharply, with the International Diabetes Federation estimating approximately 537 million adults living with diabetes in 2021, projected to reach 700 million by 2045 [1]. This epidemic drives sustained demand for effective pharmacological therapies.

The increasing geriatric population, urbanization, and sedentary lifestyles contribute to this trend, creating a perennial demand for antihyperglycemic medications like dapagliflozin and metformin.

2. Competitive Positioning and Market Penetration

Metformin's entrenched use as first-line therapy ensures its persistent market dominance, with over 70% of T2DM patients receiving it at some point in their treatment course [2]. Meanwhile, dapagliflozin has secured a growing niche owing to its additional cardiovascular and renal benefits, positioning itself as a preferred option for patients with comorbidities.

In 2022, the global SGLT2 inhibitors market was valued at approximately $8.7 billion, with dapagliflozin capturing a significant segment. Its competitive edge stems from efficacy in reducing hospitalization for heart failure and slowing CKD progression, increasingly recognized in guidelines.

3. Regulatory and Clinical Developments

Regulatory approvals have expanded dapagliflozin's indications beyond glycemic control, including heart failure (approved by FDA in 2020 for heart failure with reduced ejection fraction) and CKD, fostering broader market relevance [3]. Conversely, metformin's patent expired decades ago, leading to proliferation of generic versions, which sustains affordability and access but limits pricing power.

4. Patent Expiry and Generic Competition

Generic flooding has kept metformin prices low, maintaining its widespread prescribing. Dapagliflozin, with patent protection until 2027, remains protected from generics, allowing AstraZeneca to optimize pricing and market share.

5. Market Challenges and Trends

Key challenges include therapeutic adherence, side effect profiles (e.g., genital infections with dapagliflozin, gastrointestinal issues with metformin), and patient-specific considerations. The trend toward personalized medicine and combination therapies (e.g., fixed-dose combinations of metformin and dapagliflozin) is prominent, aiming to enhance adherence and treatment efficacy.

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Financial Trajectory

1. Revenue Trends and Forecasts

Dapagliflozin sales have demonstrated robust growth, with AstraZeneca reporting revenues of approximately $2.5 billion globally in 2022, representing a CAGR of around 20% since 2018. The increased adoption in cardiometabolic indications and strategic geographic expansion underpin this growth.

Metformin remains a highly affordable and prescribed medication globally. Its revenue generation is less about incremental sales and more about sustaining high-volume, low-margin sales, especially in regions with limited healthcare spending.

Future forecasts project continued growth for dapagliflozin—expected to reach $4 billion to $6 billion by 2030—driven by expanding indications, penetrance in emerging markets, and ongoing clinical validation.

Conversely, metformin's revenues are expected to stabilize or decline modestly in developed markets due to generic competition but will sustain high volume due to affordability.

2. Pricing and Market Access

Dapagliflozin commands premium pricing resulting from its added benefits, especially in North America and Europe. Pricing strategies vary across geographies, influenced by healthcare policies and reimbursement frameworks.

Metformin’s pricing is heavily influenced by generic availability, with costs as low as a few cents per tablet, making it the most accessible antihyperglycemic agent worldwide.

3. R&D Investments and Pipeline

Investment in dapagliflozin's pipeline includes:

• New combinations with other antidiabetics.
• Expanded indications (e.g., non-alcoholic fatty liver disease).
• Novel formulations (extended-release, fixed-dose combinations).

These investments aim to extend product life cycle, boost sales, and mitigate competition.

Metformin's patent expiration has curtailed R&D efforts focused solely on it but spurred interest in enhancements such as controlled-release formulations and combination therapies.

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Market Opportunities and Risks

Opportunities:

• Evolving guidelines favoring SGLT2 inhibitors for cardiorenal protection.
• Growth in emerging markets with rising diabetes prevalence.
• Strategic collaborations for combination therapies.

Risks:

• Regulatory hurdles in expanding indications.
• Side effects impacting tolerability and adherence.
• Competition from other SGLT2 inhibitors and newer agents (e.g., GLP-1 receptor agonists).

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Conclusion

The market landscape for dapagliflozin and metformin hydrochloride reflects broader trends in diabetes management: sustained growth driven by rising prevalence, expanding indications, and evolving treatment paradigms. While metformin maintains its foundational position owing to cost and efficacy, dapagliflozin’s innovative profile and multi-indication approvals promise substantial revenue growth, enhancing its role in cardio-renal disease management.

Strategic investments and adaptive market strategies will be pivotal for pharmaceutical companies aiming to capitalize on this trajectory. Emphasizing safety profile improvements, expanding geographic reach, and pioneering combination therapies constitute critical pathways toward capturing market share.

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Key Takeaways

• Rising diabetes prevalence globally sustains demand for both traditional and novel therapies.
• Metformin remains the most prescribed, cost-effective antihyperglycemic, but faces market saturation with declining growth prospects.
• Dapagliflozin exhibits a strong growth trajectory driven by expanded indications, innovative formulations, and favorable clinical data.
• Regulatory approvals for cardiovascular and renal benefits are pivotal in driving dapagliflozin’s market expansion.
• Emerging markets present significant growth opportunities, especially as affordability and access improve.

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FAQs

Q1: What factors are driving the increased adoption of dapagliflozin over other SGLT2 inhibitors?
A: Dapagliflozin benefits from robust clinical data supporting its efficacy in heart failure and CKD, regulatory approvals for multiple indications, and strategic marketing by AstraZeneca, positioning it favorably relative to competitors.

Q2: How does the patent status of dapagliflozin influence its market revenue?
A: Patent protection until 2027 allows AstraZeneca to maintain premium pricing and prevent generic competition, directly influencing revenue stability and growth.

Q3: Will metformin remain relevant amid newer drugs like dapagliflozin?
A: Yes, due to its low cost, proven safety, and efficacy, metformin remains the first-line therapy globally, especially in resource-limited settings, though its market share may shift with the advent of combination therapies.

Q4: What are the main challenges for dapagliflozin’s market expansion?
A: Challenges include managing side effects, navigating regulatory pathways for additional indications, and competing with other SGLT2 inhibitors and emerging therapies.

Q5: How might healthcare policies influence the future financial trajectory of these drugs?
A: Policies prioritizing cost-effective therapies and reimbursement for innovative drugs will favor dapagliflozin’s growth, while increased pressure on healthcare costs could hamper pricing strategies for newer agents.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2021.
[2] American Diabetes Association. Standards of Medical Care in Diabetes—2022.
[3] U.S. Food and Drug Administration. FDA Approvals and Indication Updates, 2020–2022.