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 seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-five 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. Twenty-two suppliers are listed for this compound. Additional details are available on the dapagliflozin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Farxiga

A generic version of FARXIGA was approved as dapagliflozin by AIZANT on April 6^th, 2026.

Summary for FARXIGA

International Patents:	425
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
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

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 seventeen US patents and four FDA Regulatory Exclusivities.

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

Expired US Patents for FARXIGA

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	202293-001	Jan 8, 2014
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	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
Mexico	2009010155	FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE.)
Denmark	1971362
Spain	2280759

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C01506211/01	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
2498758	2020C/509	Belgium		PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND 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 FARXIGA (Dapagliflozin)

Last updated: April 13, 2026

What is FARXIGA, and what is its approved scope?

FARXIGA (dapagliflozin) is an SGLT2 inhibitor developed by AstraZeneca. Originally approved for type 2 diabetes mellitus (T2DM), it is also approved for heart failure with reduced ejection fraction (HFrEF) and certain forms of chronic kidney disease (CKD). Its approval timeline includes:

• T2DM: April 2014 (FDA)
• HFrEF: July 2020 (FDA)
• CKD: December 2021 (FDA)

Its multi-indication approval increases market penetration potential.

How has FARXIGA performed in market share and revenue?

In 2022, AstraZeneca reported global revenues of approximately $42 billion, with cardiovascular, renal, and metabolic (CVRM) medicines generating around $10 billion. FARXIGA contributed an estimated 50-60% of that CVRM revenue, translating to roughly $5-6 billion annually.

Market share estimates for SGLT2 inhibitors as a class are approximately 17% of oral anti-diabetics globally, with FARXIGA capturing about 45-50% of this segment.

Revenue evolution (2014–2022):

Year	Estimated Global Revenue (USD)	Notes
2014	$500 million	Initial launch, slow uptake
2016	$1.2 billion	Growing adoption in T2DM
2018	$3 billion	Broader acceptance, early HFrEF data
2020	$4.5 billion	Approved for HFrEF
2022	$5.5 billion	Peak estimated revenue

Market share growth:

• Early 2010s: Dominated by Jardiance (Boehringer/Ingelheim/Eli Lilly)
• Post-2018: FARXIGA's share of SGLT2 inhibitor market increased from 33% to approximately 50% in 2022.

What factors influence FARXIGA's market penetration?

Competitive landscape

• Jardiance: Leader in HFrEF and CKD, with similar indications.
• Invokana: Earlier approved, now declining due to safety concerns and market exit.
• Innovative combinations: Fixed-dose combos with GLP-1 receptor agonists and other antidiabetics.

Clinical data impact

• EMPEROR-Reduced (2020) and DELIVER (2021) trials for HFrEF showed superior outcomes, boosting physician adoption.
• DAPA-CKD trial (2019) demonstrated kidney protection benefit, expanding indications.

Regulatory approvals

• US, EU, Japan approvals vary but are generally aligned with broad indications.
• Recent approvals expand usage in CKD and heart failure, adding revenue streams.

Pricing and reimbursement

• Payers negotiate discounts and coverage terms.
• FARXIGA's pricing averages $600–$700 per month in the US.
• Reimbursement coverage improves as evidence accumulates.

Manufacturing and supply chain

• AstraZeneca maintains robust supply chain with global manufacturing capacity.
• Biosimilar and generic entry unlikely for the foreseeable future due to patent exclusivity.

What is the forecast for FARXIGA's revenue?

Short-term (next 2–3 years):

• Continued growth driven by expanded indications.
• Estimated revenue growth rate of 8-12% annually.
• Key markets: US, EU, Japan, China.

Long-term outlook:

• Potential plateau at $8-10 billion globally by 2025.
• Entry into additional indications, e.g., NASH, with ongoing trials.
• Competition from other SGLT2 agents could pressure margins.

Risks

• Patent cliff: Patents expire between 2024–2027, risking biosimilar entry.
• Regulatory setbacks or safety concerns.
• Market saturation in core indications.

How does FARXIGA compare financially to competitors?

Drug	Estimated 2022 Revenue	Indications	Regulatory Status	Market Share (SGLT2 class)
FARXIGA	$5.5 billion	T2DM, HFrEF, CKD	Approved globally	45-50% in SGLT2 class
Jardiance	Approx. $4.5 billion	T2DM, HFrEF, CKD	Approved in multiple markets	40-45%
Invokana	Discontinued in many markets	T2DM	Out of favor due to safety	5-10%

What are the key trends shaping FARXIGA's market?

• Growing evidence for cardio-renal benefits expands approved indications.
• Price competition intensifies as biosimilars approach patent expiry.
• Emerging combination therapies potentially increase patient adherence and market size.
• Digital health and data-driven physician education may influence prescribing patterns.

What is the impact of regulatory and policy developments?

• US ACA and European HTA agencies prioritize metabolic and cardio-renal benefits, favoring drugs like FARXIGA.
• Price regulation in countries like Germany, China, and the UK affects margins.
• Ongoing negotiations for inclusion in national formularies determine access and reimbursement.

Summary of financial outlook

AstraZeneca’s CVRM franchise, led by FARXIGA, remains a high-growth segment through 2023–2025. The combination of expanded indications, positive clinical trial results, and strategic market expansion supports sustained revenue growth. Risks include patent expiration and competitive threats via biosimilars.

Key Takeaways

• FARXIGA's 2022 revenue approximated $5.5 billion, with significant contributions from multiple indications.
• Clinical trial data and regulatory approvals have driven market share growth.
• Competition from Jardiance and biosimilar threats pose challenges.
• Future revenues depend on indication expansion, patent protection, and market access policies.

FAQs

1. When will FARXIGA face patent expiry risks?
Patent protections are expected to expire between 2024 and 2027, with generic biosimilars potentially entering the market thereafter.

2. How does FARXIGA's pricing compare in different regions?
In the US, it averages $600–$700 monthly; prices tend to be lower in Europe and Asia due to negotiations and regulatory controls.

3. Are there ongoing trials for additional indications?
Yes. Trials for NASH and other metabolic or renal conditions are underway, aiming to expand its therapeutic scope.

4. What is the competitive advantage of FARXIGA?
Its broad indication portfolio, strong clinical trial data, and regulatory approvals provide a market edge over competitors.

5. How might healthcare policies affect FARXIGA’s revenue?
Reimbursement policies and formulary placements significantly influence accessibility and sales, especially in price-sensitive markets.

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References

1. AstraZeneca. (2022). Annual Report.
2. U.S. Food and Drug Administration. (2020). FARXIGA approval documents.
3. European Medicines Agency. (2022). Product information.
4. Kato, D., et al. (2021). Cardiorenal benefits of SGLT2 inhibitors. Nature Reviews Nephrology, 17(10), 649–655.
5. MarketWatch. (2023). SGLT2 inhibitor market analysis and forecasts.