DAPAGLIFLOZIN - Generic Drug Details

What are the generic sources for dapagliflozin and what is the scope of patent protection?

Dapagliflozin is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in four NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has four hundred and fifty patent family members in fifty-two countries.

There are twenty-six drug master file entries for dapagliflozin. Five suppliers are listed for this compound. There are sixteen tentative approvals for this compound.

Summary for DAPAGLIFLOZIN

International Patents:	450
US Patents:	21
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	542
Patent Applications:	6,063
Drug Prices:	Drug price trends for DAPAGLIFLOZIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPAGLIFLOZIN
What excipients (inactive ingredients) are in DAPAGLIFLOZIN?	DAPAGLIFLOZIN excipients list
DailyMed Link:	DAPAGLIFLOZIN at DailyMed

See drug prices for DAPAGLIFLOZIN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN

Dosage:

TABLET;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

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

Sponsor	Phase
University of Aberdeen	NA
Centre Hospitalier Universitaire de Nice	PHASE2
NHS Grampian	NA

See all DAPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN

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

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

Anatomical Therapeutic Chemical (ATC) Classes for DAPAGLIFLOZIN

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FARXIGA	Tablets	dapagliflozin	5 mg and 10 mg	202293	20	2018-01-08

US Patents and Regulatory Information for DAPAGLIFLOZIN

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	205649-002	Oct 29, 2014		RX	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	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No					Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No					Y

Expired US Patents for DAPAGLIFLOZIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014

EU/EMA Drug Approvals for DAPAGLIFLOZIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Forxiga	dapagliflozin	EMEA/H/C/002322Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2012-11-11
AstraZeneca AB	Edistride	dapagliflozin	EMEA/H/C/004161Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.	Authorised	no	no	no	2015-11-09
Viatris Limited	Dapagliflozin Viatris	dapagliflozin	EMEA/H/C/006006Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.	Authorised	yes	no	no	2023-03-24

International Patents for DAPAGLIFLOZIN

Country	Patent Number	Title	Estimated Expiration
Lithuania	3524261
Spain	2950089
Denmark	3524261
Japan	4899021
Hong Kong	1176004
European Patent Office	1958623	Microcapsules à libération prolongée à base de poly(Lactide-Co-Glycolide) comportant un polypeptide et un sucre (Poly(Lactide-Co-Glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar)

Supplementary Protection Certificates for DAPAGLIFLOZIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1506211	2013/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	2020C/533	Belgium		PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
2139494	C20200028 00358	Estonia		PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
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

Market Dynamics and Financial Trajectory for Dapagliflozin

Last updated: July 28, 2025

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Introduction

Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has established a significant footprint within the global pharmaceutical landscape as a front-line therapy for type 2 diabetes mellitus (T2DM). Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, the drug has expanded its scope to include indications for heart failure and chronic kidney disease, thereby augmenting its market potential. This article analyzes the current market dynamics, competitive positioning, regulatory developments, and financial trajectory of dapagliflozin while offering strategic insights pertinent to stakeholders.

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Market Overview and Key Drivers

Global Market Size and Growth Trajectory

The global SGLT2 inhibitors market was valued at approximately USD 12 billion in 2022 and is projected to reach around USD 25 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 10-12% (2023–2030) [1]. Dapagliflozin, as one of the leading drugs in this class, accounts for a substantial share of this growth, buoyed by its expanding indications.

Evolving Indications Enhancing Market Reach

Initially approved for T2DM, dapagliflozin’s subsequent indications include:

• Heart failure with reduced ejection fraction (HFrEF)
• Chronic kidney disease (CKD)

The FDA approvals for HFrEF (2020) and CKD (2021) have driven incremental revenue streams, diversify its revenue base, and extend its lifecycle beyond diabetes management, aligning with prevailing clinical needs for comprehensive cardiometabolic therapy [2].

Key Market Drivers

• Rising Prevalence of T2DM and Cardiovascular Diseases (CVD): The global diabetes population is expected to reach 700 million by 2045, with CVD being a leading comorbidity. Growing disease burden accelerates demand for effective therapies like dapagliflozin [3].
• Guideline Endorsements: Favorable recommendations from ADA and ESC guidelines for SGLT2 inhibitors in managing heart failure and CKD amplify prescribing rates.
• Advancements in Drug Formulation: Fixed-dose combinations and sustained-release formulations improve patient compliance and expand market penetration.
• Emerging Markets Expansion: Increased access, affordability initiatives, and health infrastructure enhancements are facilitating uptake in emerging economies, particularly in Asia-Pacific and Latin America.

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Market Challenges and Competitive Landscape

Intense Competition

Dapagliflozin faces competitive pressures from other SGLT2 inhibitors such as empagliflozin (Jardiance), canagliflozin (Invokana), and ertugliflozin (Steglatro). Major pharmaceutical players—Boehringer Ingelheim (gliflozin copayments), AstraZeneca, and Merck—are heavily investing in R&D and marketing, intensifying rivalry.

Pricing Pressure and Reimbursement Dynamics

Pricing strategies are pivotal, especially in cost-sensitive markets. Reimbursement policies often favor newer or more established alternatives, potentially impacting market share.

Regulatory Hurdles and Off-Label Risks

While expanded indications support growth, regulatory scrutiny remains a risk, especially regarding long-term safety data. Off-label use may pose legal and ethical challenges, influencing sales trajectories.

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Regulatory and Clinical Development Trends

Recent and upcoming regulatory decisions are shaping dapagliflozin’s prospects:

• Positive Outcomes in CVOTs: The DECLARE-TIMI 58 trial demonstrated significant cardiovascular and renal benefits, bolstering market penetration for heart failure and CKD [4].
• Label Expansion: The FDA’s approval for HFrEF widens dapagliflozin’s therapeutic scope, aligning with an aging population afflicted by multiple comorbidities.
• Off-Label and Future Indications: Studies investigating dapagliflozin’s role in non-alcoholic fatty liver disease, polycystic ovary syndrome, and heart failure with preserved ejection fraction (HFpEF) could further expand its market.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Since its launch, dapagliflozin has generated substantial revenues. In 2022, sales surpassed USD 4 billion globally, marking its position as a top-performing SGLT2 inhibitor (source: IQVIA). Revenue growth has been driven by:

• Increased adoption for T2DM
• Expanded indications for heart failure and CKD
• Steady penetration into new markets

Projection Analysis

Analysts project that dapagliflozin’s revenue could reach between USD 7 to 10 billion by 2030, aligned with the broader SGLT2 inhibitor market expansion. Key factors influencing this trajectory include:

• Market Adoption Rates: The pace of guideline recommendations and clinician acceptance.
• Regulatory Approvals: Timely expansion into new indications.
• Pricing Strategies: Competitive pricing will be crucial in emerging markets.
• Patent Expiry and Biosimilar Entry: Patent protections extending into the mid-2020s provide revenue stability, but biosimilars or generics could erode margins thereafter.

Impact of Healthcare Economics

Cost-effectiveness analyses favor dapagliflozin due to its dual benefits on glycemic control and cardiovascular outcomes, facilitating reimbursement. Governments and insurers’ willingness to cover these innovative therapies significantly impacts revenue growth, especially in value-based care models.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Emphasis on clinical trial investments to demonstrate benefits across diverse populations, geographies, and comorbidities.
• Investors: Monitoring pipeline advancements, patent landscapes, and regulatory decisions will be vital in assessing long-term valuation.
• Health Authorities: Clear policies promoting access to evidence-based treatments can accelerate dapagliflozin’s market expansion.
• Clinicians: Staying updated on evolving guidelines ensures optimal patient management and drug utilization.

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Key Market Opportunities

• Expansion into Emerging Markets: Opportunities for growth in APAC, Latin America, and Africa through pricing, partnerships, and localized marketing.
• Combination Therapies: Developing fixed-dose combinations with other antihyperglycemics or cardioprotective agents.
• Digital and Remote Monitoring Integration: Enhancing adherence through digital health solutions.

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Risks and Mitigation Strategies

• Market Saturation: Diversify indications and geographies to counteract saturation in mature markets.
• Regulatory Setbacks: Maintain robust post-marketing surveillance and safety data to preempt restrictions.
• Competitive Innovation: Invest in next-generation SGLT2 inhibitors and alternatives with improved efficacy or safety profiles.

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Conclusion

Dapagliflozin’s market dynamics are characterized by robust growth driven by expanding indications, favorable clinical evidence, and increasing prevalence of target conditions. Financial projections suggest sustained revenue growth, contingent on strategic positioning amidst competitive and regulatory landscapes. Stakeholders must focus on clinical innovation, pricing strategies, and global expansion to optimize financial outcomes.

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Key Takeaways

• Dapagliflozin is positioned at the forefront of the rapidly growing SGLT2 inhibitor market, supported by broadening indications and guideline endorsements.
• Market growth is fueled by the increasing burden of diabetes, heart failure, and CKD globally and in emerging markets.
• The drug’s financial trajectory promises substantial revenue streams, potentially surpassing USD 10 billion annually by 2030, contingent on continued clinical and regulatory success.
• Competition, pricing pressures, and patent expirations remain key risks requiring proactive strategic responses.
• Stakeholders should focus on pipeline development, market expansion, and patient access initiatives to sustain competitiveness and maximize ROI.

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FAQs

1. What are the primary factors driving dapagliflozin’s market growth?
   The primary drivers include expanding approved indications (heart failure, CKD), increased prevalence of diabetes, clinical guideline endorsements, and strategic penetration in emerging markets.

2. How does dapagliflozin compare to other SGLT2 inhibitors in terms of market share?
   While dominant in certain markets, dapagliflozin competes closely with empagliflozin and canagliflozin, with its broader indications and positive trial results supporting its competitive stance.

3. What challenges could impede dapagliflozin’s financial growth?
   Challenges include intense competition, patent expirations, regulatory restrictions, and pricing pressures in cost-sensitive regions.

4. Are there upcoming regulatory decisions that could impact dapagliflozin’s market?
   Future decisions regarding additional indications, safety labeling, and post-marketing commitments will influence its market trajectory.

5. What strategies can maximize dapagliflozin’s long-term market potential?
   Strategies include expanding indications through clinical trials, entering emerging markets, fostering payer partnerships, and leveraging digital health tools for patient adherence.

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References

[1] Market Research Future. “SGLT2 inhibitors Market Report.” 2022.
[2] U.S. Food and Drug Administration. “FDA approves dapagliflozin for heart failure.” 2020.
[3] International Diabetes Federation. “Diabetes Atlas, 10th Edition.” 2021.
[4] FDA. “DECLARE-TIMI 58: Dapagliflozin and Cardiovascular Outcomes.” 2019.