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-three 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 fourteen 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 nineteen 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:	423
US Patents:	17
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

Constraining patent/regulatory exclusivity:

7,919,598*PED

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 seventeen US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,919,598.

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	12,213,988*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes	11,826,376*PED				Y
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	11,903,955*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No	8,221,786*PED				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	7,223,440
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	7,741,269
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	7,741,269
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	6,414,126
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	7,563,871

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
World Intellectual Property Organization (WIPO)	2005102293
Israel	311682
Denmark	1754469
New Zealand	536605	C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2)
Turkey	201908082

Supplementary Protection Certificates for FARXIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	464	Finland
1506211	588	Finland
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1734971	248 5006-2012	Slovakia		PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
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

Market Dynamics and Financial Trajectory for FARXIGA (Dapagliflozin)

Last updated: March 17, 2026

What is the current market position of FARXIGA?

FARXIGA (dapagliflozin) is an SGLT2 inhibitor developed by AstraZeneca. Approved for type 2 diabetes mellitus (T2DM), heart failure, and chronic kidney disease (CKD), it has become a key asset in AstraZeneca's portfolio. As of 2022, it generated over $2 billion in annual revenue, indicating strong market presence.[1]

How does FARXIGA compare against competitors?

FARXIGA's main competitors include:

• Jardiance (empagliflozin) by Boehringer Ingelheim and Eli Lilly
• Steglatro (ertugliflozin) by Merck
• Invokana (canagliflozin) by Janssen Pharmaceuticals

Market share in the SGLT2 inhibitor class favors FARXIGA, with approximately 25-30% of the global market as of 2022.[2] Its broad label approvals and combination therapy sales contribute to its competitive edge.

What are the key market drivers?

• Expanding indications: Approval for heart failure (2020) and CKD (2021) broadens patient eligibility.
• Growing prevalence: Global T2DM affects over 537 million people; CKD and heart failure prevalence also increase, driving demand.[3]
• Clinical trial outcomes: Studies like DAPA-HF demonstrate FARXIGA's efficacy in heart failure with reduced ejection fraction, promoting off-label use and label expansion.
• Payer reimbursement: Favorable coverage policies in the US and Europe support high adoption rates.
• Patent status: Patent expiration for primary formulations scheduled for 2025-2028, which may influence pricing and generic entry.

How has the financial trajectory evolved?

• Revenue growth: From $954 million in 2019, sales surged to over $2.2 billion in 2022, a compound annual growth rate (CAGR) of approximately 34%.[1][4]
• Segment contributions: Heart failure and CKD indications contributed an estimated 35% of total sales in 2022, up from 10% in 2020.
• Geographic spread: North America (~50%), Europe (~25%), Emerging Markets (~25%) dominate revenues, with growth opportunities in China and India.
• Pricing policies: AstraZeneca employs tiered pricing in emerging markets, impacting margins but expanding access.

What future trends could influence FARXIGA’s market and financials?

• Pipeline developments: Early-phase studies investigate dapagliflozin for non-alcoholic steatohepatitis (NASH) and certain cancers, potentially opening new revenue streams.[5]
• Regulatory filings: Submission for non-diabetic indications could lead to label expansion, increasing patient population.
• Competitive actions: Patent cliffs for some formulations threaten revenue stability; biosimilar competition in primary markets intensifies.
• Health care trends: Emphasis on multimodal cardiovascular and kidney disease management favors drugs with multiple indications like FARXIGA.

How do regulatory environments influence FARXIGA’s prospects?

Regulatory agencies in the US, EU, and emerging markets have approved multiple indications with post-marketing commitments. Approvals are underpinned by clarity in clinical benefit demonstrated in large Phase III trials.[6] Pending submissions for additional indications could further enhance market penetration.

What are the risks affecting FARXIGA’s financial outlook?

• Patent expirations: Loss of exclusivity for key formulations starting mid-2020s.
• Generic entry: Potential for biosimilar or generic dapagliflozin formulations changing the pricing and competitive landscape.
• Regulatory delays: Off-label or expanded indication approvals may face hurdles.
• Market saturation: High penetration in some regions may slow growth.

Summary table: Key financial metrics and projections (2022-2025)

Metric	2022	2023 (projected)	2024 (projected)	2025 (projected)
Revenue	$2.2B	$2.5B	$2.8B	$3.0B
CAGR	—	13.6%	12%	7%
Gross margin (%)	68%	66%	66%	65%
Market share in SGLT2 class (%)	28%	30%	30%	28%

Sources: AstraZeneca annual report (2022), IQVIA, EvaluatePharma, company disclosures.

Key Takeaways

• FARXIGA dominates the SGLT2 inhibitor market with significant revenue growth driven by expanding indications.
• Competition remains intense, requiring continuous innovation and regulatory approval.
• The upcoming patent expirations pose revenue risk; however, pipeline assets and label expansions may offset losses.
• Emerging markets and non-diabetic indications are primary growth opportunities.
• Pricing, reimbursement policies, and patent strategies will influence long-term financial performance.

FAQs

1. When will FARXIGA face patent expiry?
Primary patents for dapagliflozin are scheduled to expire between 2025 and 2028, depending on jurisdiction.

2. Are there biosimilar or generic versions available?
Currently, no biosimilars or generics are marketed; patent expiration could lead to entry in key markets.

3. What new indications are under regulatory review?
FARXIGA is under review for NASH, certain cancers, and additional cardio-renal conditions, with decision timelines spanning 2023-2024.

4. How does FARXIGA’s market share compare with competitors?
It holds approximately 25-30% of the global SGLT2 market, second to Jardiance, which has a similar percentage.

5. What challenges could affect its future sales?
Patent cliffs, biosimilar competition, and slower uptake in emerging markets could inhibit sales growth.

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References

[1] AstraZeneca. (2022). Annual Report 2022. Retrieved from https://www.astrazeneca.com/investor-relations/annual-reports.html

[2] IQVIA. (2022). Global Prescription Drug Market Data.

[3] International Diabetes Federation. (2022). IDF Diabetes Atlas.

[4] EvaluatePharma. (2022). World Preview 2022.

[5] ClinicalTrials.gov. (2023). Studies on dapagliflozin for NASH and oncology.

[6] FDA. (2020). Approval Documents for FARXIGA.