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-seven patent family members in fifty-three countries.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this compound. Twenty-four 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:	427
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
UnitedHealthcare	PHASE2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	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
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	AB	RX	Yes	Yes					Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	AB	RX	Yes	No					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					Y

Expired US Patents for FARXIGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014
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
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	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
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
Australia	781009
Australia	7848300	C-aryl glucoside sglt2 inhibitors

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C300585	Netherlands		PRODUCT NAME: DAPAGLIFLOZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	PA2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	122013000033	Germany		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	92182	Luxembourg		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1506211	2013/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211	CA 2013 00019	Denmark

FARXIGA (dapagliflozin) Market Dynamics and Financial Trajectory: Exclusivity, Patent Risk, and Competitive Outlook

Last updated: June 23, 2026

FARXIGA is a leading SGLT2 inhibitor for type 2 diabetes and a cornerstone cardiovascular and renal franchise. The asset’s financial trajectory is driven by U.S. and ex-U.S. expansion, uptake in heart failure and chronic kidney disease populations, and resilience against GLP-1 and other diabetes competitors. The IP and regulatory risk profile is shaped by ongoing U.S. patent estates for formulations, dosing regimens, and specific clinical method-of-use claims, alongside biosimilar-free competitive pressure from other small-molecule SGLT2 inhibitors.

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How does FARXIGA perform financially and what is driving revenue growth?

Direct answer: FARXIGA’s revenue trajectory is powered by (1) growing chronic indications footprint in heart failure and CKD, (2) substitution away from older glucose-centric diabetes-only positioning, and (3) continued broad payer acceptance in the U.S. SGLT2 inhibitor class.

Revenue drivers by commercial line

FARXIGA’s commercial dynamics are best understood as a multi-indication engine:

1) Type 2 diabetes

• Maintains base demand as the SGLT2 category matures.
• Growth is influenced by guideline incorporation, formulary positioning, and 2nd-line switching dynamics versus DPP-4 inhibitors and parts of GLP-1 regimens depending on access and outcomes evidence.

2) Heart failure

• The franchise has moved beyond diabetes-only prescribing.
• Uptake depends on payer adoption, hospital formulary behavior, and guideline-aligned treatment pathways.

3) Chronic kidney disease

• CKD adoption is sensitive to nephrology referral patterns and outcomes data assimilation in payer criteria.
• Dosing convenience and tolerability profile support broader maintenance use.

Key financial inflection mechanisms

Across the SGLT2 class, revenue growth is typically shaped by:

• Utilization expansion into non-diabetes populations.
• Net price and rebates shaped by U.S. contracting intensity and class competition.
• Dose and patient persistence driven by adverse event management (notably genital infections, volume depletion, and rare diabetic ketoacidosis concerns).
• Competitive interchange between branded products and less-expensive generics where patent and exclusivity allow.

Competitive forces affecting net sales

• Within-class: price pressure from empagliflozin (Jardiance) and other SGLT2 inhibitors.
• Cross-class: GLP-1 receptor agonists and dual GIP/GLP-1 agents compete for diabetes volumes and obesity-driven cardiometabolic share.
• Formulary policy: more restrictive step therapy for diabetes may coexist with more permissive access for heart failure and CKD indications, shifting mix.

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What market dynamics shape FARXIGA demand in the SGLT2 inhibitor category?

Direct answer: The category is characterized by rapid indication expansion, payer-driven contracting, and increasing interchange between SGLT2 molecules, with guideline-based adoption in cardiovascular and kidney care sustaining demand even as diabetes-only growth normalizes.

SGLT2 market structure

• High clinical credibility: outcomes data supports guideline embedding.
• Payer management: rebates and preferred formulary status determine share at the margin.
• Clinical substitution: many clinicians treat SGLT2 inhibitors as a class, changing the importance of access and patient-specific tolerability.

Adverse event management as a commercial lever

• Commercial persistence improves when real-world adverse event rates are managed via patient selection, education, and early intervention for mycotic infections.
• Safety perceptions can affect switching behavior when competing SGLT2 products have different patient-matched tolerability experiences.

Patient access and health system adoption

• Heart failure and CKD prescribing is fragmented across cardiology, nephrology, and primary care.
• Access is affected by prior authorization rules, CKD staging documentation requirements, and disease-criteria alignment.

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When does FARXIGA lose exclusivity and what are the patent drivers?

Direct answer: FARXIGA’s U.S. exclusivity and patent landscape is anchored by multiple overlapping protection layers. The practical exclusivity timeline is determined by the latest expiring U.S. patents for specific claims (including method-of-use and formulation/dosing-related claims) and any Orange Book-protected exclusivities tied to FDA approvals.

Exclusivity stack concept

For small molecules, exclusivity risk is typically less about biologics exclusivity mechanics and more about:

• Patent expiration for composition-of-matter, formulation, and method-of-use claims.
• Regulatory exclusivity (new chemical entity and related categories) when still applicable.
• Orange Book listing status for each relevant strength/dosage form.

Ongoing litigation and “evergreening” patterns

In the SGLT2 inhibitor space, generic entry strategy usually targets:

• Later-expiring formulation or method-of-use patents.
• Specific dosing regimen claims tied to clinical outcomes indications.

Result: the near-term entry risk is often delayed if challengers must navigate multiple listed patents covering commercial products.

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What patents protect FARXIGA in the US and how strong is the patent estate?

Direct answer: FARXIGA is protected by a multi-layer U.S. patent estate that typically includes composition, formulation, and method-of-use claims, with strength depending on whether patents are listed in the Orange Book for the commercial NDA and whether they have survived litigation.

What claim types matter commercially

1. Method-of-use patents

• Protect clinical indication-specific dosing and use, often controlling generic launch for labeled populations.

2. Formulation and stability patents

• Can block “skinny labels” if they are tied to the approved product dosage form.

3. Combination or regimen claims

• More relevant where label evolution aligns with specific use patterns.

How to evaluate strength for licensing and litigation

• Patents with broad claims spanning multiple indications create launch friction even if challengers can carve out some uses.
• Patents with narrower claim construction create more predictable “design-around” opportunities, lowering litigation value.

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How many Paragraph IV challenges target FARXIGA and what is the litigation track record?

Direct answer: FARXIGA has faced the U.S. generic challenge ecosystem typical for high-selling branded small molecules, with challengers using Paragraph IV filings to attempt earlier entry against Orange Book-listed patents.

Typical litigation outcomes that shape market entry

• Dismissal or non-infringement shifts the entry date beyond the expected earliest generic launch.
• Settlement agreements commonly trade earlier entry for licensing payments and defined launch timing.
• Court invalidation can accelerate entry for certain strengths but may not fully eliminate indication-specific barriers.

Settlement-driven entry calendars

For portfolio planning, the practical lens is:

• The earliest FDA approval/launch date permitted under settlement.
• The covered patent list remaining intact.
• The scope of label (skinny label vs full label) after resolution.

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What is the Orange Book status of FARXIGA and how does it affect generic entry?

Direct answer: Orange Book listings for FARXIGA determine which patents must be addressed by an FDA Paragraph IV filing and drive the injunction risk framework.

How Orange Book listings translate into regulatory risk

• If a Paragraph IV challenger does not secure a carve-out, courts can enjoin approval/launch.
• A strong listing for method-of-use claims can still limit generic access to certain labeled indications even after patent loss on composition.

Strength of Orange Book coverage

Orange Book protection is generally stronger when:

• Multiple patents are listed per NDA and strength.
• Method-of-use patents align with the commercial label used in real-world prescribing.

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How does FARXIGA compare with Jardiance and other SGLT2 inhibitors on competitive risk?

Direct answer: The SGLT2 market is a competitive set where head-to-head switching is common, but brand-specific patent timing and Orange Book coverage shape generic substitution windows.

Competitive comparison by commercial posture

• Jardiance (empagliflozin) competes directly across diabetes and cardiovascular/renal indications.
• Other SGLT2 inhibitors compete on formulary access, safety perception, and clinician familiarity.

Where FARXIGA’s dynamics tend to differ

• Indication-specific uptake in heart failure and CKD can change the mix of sales and protect demand when diabetes-only utilization flattens.
• Patent timing and settlement outcomes affect how soon payers and providers can switch to lower-cost alternatives.

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What formulations are protected for FARXIGA and what does that mean for generics?

Direct answer: FARXIGA’s protected dosage forms and formulation attributes influence whether generics can launch for all strengths and whether they must use complex design-around strategies.

Formulation-related barriers

• If formulation patents cover the approved dosage form’s composition, stability, or delivery characteristics, generic manufacturers face higher risk of infringement claims.
• Formulation patents can also complicate “label carve-out” strategies if they cover the marketed product irrespective of indication.

Dosing strength and manufacturing approach

• Different strengths can have different listed patent coverage.
• Manufacturing methods are rarely the main barrier for branded small molecules unless specific method patents are asserted, but formulation patents can still impose.

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What method-of-use patents cover FARXIGA and how do they impact skinny-label launches?

Direct answer: Method-of-use patents for FARXIGA can delay generic entry for certain indications, forcing “carve-out” labeling to avoid infringement.

Skinny label risk logic

• Generic approval may proceed with restricted indication language.
• Commercial value depends on whether the restricted label removes the indications driving most sales.

Commercial consequence

• If the carved-out indication set targets the most profitable or highest-utilization population, generic profitability can be substantially reduced even if launch occurs.

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What biosimilar or biologics risk exists for FARXIGA?

Direct answer: No biosimilar risk applies; FARXIGA is a small-molecule drug.

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How does FDA regulatory status influence FARXIGA demand and competition?

Direct answer: FDA approval for multiple indications supports durable prescribing and lowers switching friction versus agents with narrower label coverage.

Regulatory pathway impact

• Once a brand has an expanded label, clinicians can justify continued use in broader populations.
• Competitors must match labeled outcomes to gain share, which typically requires substantial evidence.

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What generic entry risks exist for FARXIGA in different geographies?

Direct answer: Geographic risk depends on local patent enforcement and regulatory filing timelines. In the U.S., the Orange Book and Paragraph IV framework typically drive timing. In major markets, patent validity and enforcement practices determine the practical entry date.

U.S. vs EU vs other markets

• U.S.: strong linkage between FDA approval and listed patents drives litigation leverage.
• EU: patent litigation and national enforcement determine injunction ability.
• Global: transfer pricing and local contracting can affect uptake even after legal entry.

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How do licensing deals and settlements influence FARXIGA’s competitive timeline?

Direct answer: Settlements and licensing agreements typically convert a high-uncertainty litigation timeline into a defined launch schedule, shaping payer planning and generic manufacturer investment.

Settlement mechanics to model

• Launch date gates (full product vs limited label).
• Designations for covered strengths or indications.
• Exclusivity carve-outs tied to unresolved patents.

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Key patent-lifecycle checkpoints to monitor for FARXIGA

Direct answer: Patent estate value is most sensitive to the next judicial or administrative decision affecting the latest expiring Orange Book-listed patents.

What to track

• Next scheduled court events in relevant Paragraph IV actions.
• Claim construction decisions that narrow or expand infringement scope.
• Any new patent listings or removals from the Orange Book for the NDA.
• Post-grant review outcomes impacting enforceability.

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Key Takeaways

• FARXIGA’s financial trajectory is driven by label expansion and sustained clinical adoption in heart failure and CKD, not only diabetes utilization.
• The SGLT2 inhibitor market is highly competitive with class-wide interchange, making payer contracting and real-world tolerability management critical to net sales.
• Generic risk is governed by Orange Book-listed patents and method-of-use barriers that can force skinny-label launches, reducing the commercial value of generic entry.
• Patent estate strength depends on whether method-of-use and formulation claims remain enforceable and whether litigation ends in injunctions or settlement-based launch calendars.
• Biosimilar risk does not apply because FARXIGA is a small molecule.

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FAQs

1. What commercial indications contribute most to FARXIGA sales, and how do label carve-outs change generic profitability?
2. Which SGLT2 inhibitor patents typically determine the timing of generic entry in the U.S. for class members like FARXIGA and Jardiance?
3. How do payer policies for CKD and heart failure affect FARXIGA uptake compared with diabetes-first competitors?
4. What are the main real-world safety and adherence issues that influence FARXIGA persistence and switching?
5. How do Orange Book patent listing changes alter Paragraph IV risk for FARXIGA strengths and dosing regimens?

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. U.S. FDA. Drug Approval Reports and related labeling for FARXIGA (dapagliflozin). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

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