FARXIGA Drug Patent Profile

When do Farxiga patents expire, and when can generic versions of Farxiga launch?

Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Farxiga

Farxiga 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.

Annual sales in 2022 were $5.3bn, indicating a strong incentive for generic entry.

There have been eleven 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.

There are sixteen tentative approvals for the generic drug (dapagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FARXIGA

International Patents:	450
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	50
Patent Applications:	1
Drug Prices:	Drug price information for FARXIGA
Drug Sales Revenues:	Drug sales revenues for FARXIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FARXIGA
What excipients (inactive ingredients) are in FARXIGA?	FARXIGA excipients list
DailyMed Link:	FARXIGA at DailyMed

See drug prices for FARXIGA

See drug sales revenues for FARXIGA

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

NDA:

202293

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 FARXIGA

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

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	PHASE2
UnitedHealthcare	PHASE2
The University of Hong Kong	Phase 2

See all FARXIGA clinical trials

Pharmacology for FARXIGA

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

Paragraph IV (Patent) Challenges for FARXIGA

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 FARXIGA

FARXIGA is protected by nineteen US patents and four FDA Regulatory Exclusivities.

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	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes					Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes					Y

Expired US Patents for FARXIGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	202293-001	Jan 8, 2014

EU/EMA Drug Approvals for FARXIGA

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 FARXIGA

When does loss-of-exclusivity occur for FARXIGA?

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 FARXIGA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2016950	Composition pharmaceutique comportant un peptide d'exendine-4 (Pharmaceutical composition comprising an exendin-4 peptide)
Canada	2396157
Cyprus	2020022

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	464	Finland
1734971	C01734971/01	Switzerland		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1

Market Dynamics and Financial Trajectory for FARXIGA (Dapagliflozin)

Last updated: November 7, 2025

Introduction

FARXIGA (dapagliflozin), developed by AstraZeneca, is a pioneering oral sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for managing type 2 diabetes mellitus (T2DM). Over recent years, it has evolved into a versatile therapeutic agent, expanding into cardiology and nephrology indications. Understanding its market dynamics and financial trajectory is critical for stakeholders navigating the competitive landscape, regulatory challenges, and emerging therapeutic applications.

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Pharmacological Profile and Therapeutic Indications

FARXIGA functions by blocking SGLT2 in the proximal renal tubules, thereby reducing glucose reabsorption and increasing urinary glucose excretion. This mechanism yields glycemic control with added benefits in weight reduction and blood pressure management.

Initially approved in 2014 for T2DM, FARXIGA’s label has expanded significantly:

• Heart Failure with Reduced Ejection Fraction (HFrEF): Approved in 2020, expanding its use beyond glycemic control.
• Chronic Kidney Disease (CKD): In 2021, FDA and EMA approved it for CKD, independent of diabetes status.
• Post-hospitalization Heart Failure: Potential new indications are under clinical investigation.

These expanding indications position FARXIGA as a multi-asset pharmaceutical product with substantial commercial potential.

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Market Dynamics

1. Competitive Landscape

The SGLT2 inhibitor class includes medications like Janssen's Invokana (canagliflozin), Merck's Steglatro (ertugliflozin), and Boehringer Ingelheim's Jardiance (empagliflozin). FARXIGA distinguishes itself through earlier market entry and broader indication approvals, providing a competitive edge.

Key factors influencing competition:

• Efficacy and Safety Profiles: Clinical trials demonstrate FARXIGA’s comparable or superior outcomes in cardiovascular and renal protection compared to peers. Notably, the DECLARE-TIMI 58 trial marked it as the first SGLT2 inhibitor to show cardiovascular outcome benefits in a large patient cohort.

• Regulatory Timelines: Approval for non-glycemic indications accelerated commercialization opportunities, especially in cardiology and nephrology.

• Pricing and Reimbursement: Competitive pricing strategies and favorable reimbursement add to market penetration.

2. Regulatory Environment

The accelerated approval pathways for indications like HFrEF and CKD underpin a favorable environment. However, potential regulatory hurdles, such as safety concerns relating to infections, ketoacidosis, or malignancies, necessitate ongoing post-marketing surveillance, impacting long-term market confidence.

3. Market Penetration and Adoption Trends

FARXIGA’s adoption benefits from the rising prevalence of T2DM, CKD, and heart failure globally. The drug's unique positioning in multiple therapeutic areas fosters cross-indication prescribing, bolstered by clinical guideline endorsements from organizations like the American Diabetes Association (ADA), American Heart Association (AHA), and the European Society of Cardiology.

It is also favored in combination therapy regimens, further enhancing its sales potential.

4. Geographic Market Expansion

The drug’s revenue streams are concentrated in North America, Europe, and emerging markets such as Asia-Pacific. Growth in these regions will depend on local approval statuses, healthcare infrastructure, and population disease burdens.

Emerging markets present opportunities but also challenges due to pricing sensitivities and regulatory variability.

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Financial Trajectory

1. Revenue Growth Trends

Since its initial approval, FARXIGA’s global sales have demonstrated robust growth. In 2021, AstraZeneca reported approximately $3.2 billion in revenues from SGLT2 inhibitors, with FARXIGA accounting for the majority ([1]). The expansion into cardiology and nephrology indications has fueled accelerated revenue growth, with analysts projecting compound annual growth rates (CAGRs) between 15-20% over the next five years.

2. Key Revenue Drivers

• Indication Expansion: The approval for heart failure and CKD broadens the patient base beyond glycemic control.
• Market Penetration: Increased physician adoption driven by guideline endorsements.
• Combination Therapy: Synergies with other cardiovascular and renal drugs boost sales volume.
• Geographical Expansion: Growth in emerging markets complements mature markets’ steady demand.

3. Profitability Considerations

While revenue outlook remains optimistic, profitability will hinge on factors like research and development expenses, pricing pressures, and post-marketing safety investments. Patent exclusivity until at least 2030 provides a strategic pricing window.

4. Competitive Risks and Patent Challenges

Patent expirations or challenges could erode market share, especially as biosimilars or alternative therapies emerge. AstraZeneca’s portfolio diversification and ongoing pipeline investments help mitigate these risks.

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Future Outlook and Strategic Considerations

• Pipeline Development: Continuous clinical trials exploring additional indications (e.g., non-alcoholic fatty liver disease, NASH) could unlock new revenue streams.

• Collaborations and Licensing: Strategic alliances with other biotech firms for novel formulations or combination therapies could accelerate market penetration.

• Regulatory Engagement: Navigating global approval processes will remain vital, especially as safety data accumulates.

• Market Penetration Strategies: Emphasis on education and guideline endorsement can enhance prescriber confidence and patient uptake.

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Key Market Challenges

• Safety Concerns: Adverse event reports necessitate balanced risk-benefit assessments.
• Pricing Constraints: Healthcare reforms and reimbursement pressures in key markets limit pricing flexibility.
• Emerging Competition: Next-generation SGLT2 inhibitors or alternative drug classes (e.g., GLP-1 receptor agonists) threaten market share.

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Conclusion

FARXIGA’s market environment is characterized by strong growth driven by expanding indications, competitive advantages, and strategic geographic penetration. Its evolution into a comprehensive cardiometabolic and renal therapeutic positions it favorably for sustained financial growth. However, vigilant monitoring of regulatory landscapes, safety data, and competitive innovations remains essential for optimizing its commercial trajectory.

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Key Takeaways

• FARXIGA’s expansion into heart failure and CKD significantly broadens its market potential beyond diabetes management.
• The drug’s early entry and clinical success have established a solid competitive position, reinforced by robust guideline endorsements.
• Revenue growth is expected to sustain at a high double-digit CAGR, contingent on regulatory approval timelines and safety profile management.
• Competitive risks include patent challenges, emerging therapies, and safety concerns that could influence market share.
• Strategic investments in pipeline expansion, geographic growth, and partnership development are critical to maintaining its financial trajectory.

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FAQs

1. How does FARXIGA differentiate itself from other SGLT2 inhibitors?
FARXIGA was the first SGLT2 inhibitor approved for multiple indications, including heart failure and CKD, which broadens its clinical utility and market reach beyond glycemic control. Its efficacy in cardiovascular and renal protection further enhances its competitive edge.

2. What are the main challenges facing FARXIGA’s market growth?
Challenges include safety concerns related to infections and ketoacidosis, pricing pressures from healthcare systems, and competitive innovations from alternative therapies like GLP-1 receptor agonists.

3. What is the growth outlook for FARXIGA over the next five years?
Analysts project a compound annual growth rate of 15-20%, driven by indication expansion, increased adoption, and geographic market development.

4. How significant are regulatory approvals in shaping FARXIGA’s market trajectory?
Regulatory approvals are critical; they open new therapeutic indications and markets. Delays or adverse rulings could hinder growth, while supportive guidance accelerates momentum.

5. What strategic moves could AstraZeneca undertake to maximize FARXIGA’s market potential?
Investing in pipeline research for new indications, forming strategic alliances, enhancing physician education, and navigating expanding markets effectively will maximize its growth trajectory.

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References:

[1] AstraZeneca 2021 Annual Report.