INVOKANA Drug Patent Profile

Which patents cover Invokana, and when can generic versions of Invokana launch?

Invokana is a drug marketed by Janssen Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty patent family members in forty-five countries.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Invokana

Invokana was eligible for patent challenges on March 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

There have been eighteen 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 five tentative approvals for the generic drug (canagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INVOKANA

International Patents:	220
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	24
Patent Applications:	1,277
Drug Prices:	Drug price information for INVOKANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVOKANA
What excipients (inactive ingredients) are in INVOKANA?	INVOKANA excipients list
DailyMed Link:	INVOKANA at DailyMed

See drug prices for INVOKANA

See drug sales revenues for INVOKANA

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

Constraining patent/regulatory exclusivity:

7,943,582*PED

NDA:

204042

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 INVOKANA

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

Sponsor	Phase
Renal Pre-Competitive Consortium (RPC3)	PHASE4
University of Michigan	PHASE4
University of Colorado, Denver	PHASE4

See all INVOKANA clinical trials

Pharmacology for INVOKANA

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

Paragraph IV (Patent) Challenges for INVOKANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVOKANA	Tablets	canagliflozin	100 mg and 300 mg	204042	10	2017-03-29

US Patents and Regulatory Information for INVOKANA

INVOKANA is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,943,582.

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
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No	7,943,582*PED				Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes	7,943,582*PED				Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No	8,513,202*PED				Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes	7,943,788*PED				Y

EU/EMA Drug Approvals for INVOKANA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Invokana	canagliflozin	EMEA/H/C/002649Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of 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.	Authorised	no	no	no	2013-11-15

International Patents for INVOKANA

When does loss-of-exclusivity occur for INVOKANA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Guatemala

Honduras

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 INVOKANA around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20130227	FORMULACIONES FARMACEUTICAS QUE COMPRENDEN DERIVADOS DE 1-(BETA-D-GLUCOPIRANOSIL)-2-TIENILMETILBENCENO COMO INHIBIDORES DE SGLT
Argentina	045173	COMPUESTOS QUE POSEEN ACTIVIDAD INHIBITORIA CONTRA TRANSPORTADOR DE GLUCOSA DEPENDIENTE DE SODIO
Mexico	2012013090	FORMULACIONES FARMACEUTICAS QUE COMPRENDEN DERIVADOS DE 1-(BETA-D-GLUCOPIRANOSIL)-2-TIENIL-METILBENCENO COMO INHIBIDORES DE TRANSPORTADORES DE GLUCOSA DEPENDIENTES DE SODIO. (PHARMACEUTICAL FORMULATIONS COMPRISING 1 - (BETA-D-GLUCOPYRANOSYL ) - 2 -THIENYLMETHYLBENZENE DERIVATIVES AS INHIBITORS OF SGLT.)
Australia	2004260760	Novel compounds
Costa Rica	11263	COMPUESTOS NOVEDOSOS QUE POSEEN ACTIVIDAD INNHIBITORIA CONTRA TRANSPORTADOR DE GLUCOSA DEPENDIENTE DE SODIO (Solicitud divisional)

Supplementary Protection Certificates for INVOKANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	637	Finland
1651658	PA2014008,C1651658	Lithuania		PRODUCT NAME: CANAGLIFOZINUM; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/004, 2013- 11-15 EU/1/13/884/005 - EU/1/13/884/008 20131115
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658	C01651658/01	Switzerland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014

Market Dynamics and Financial Trajectory for INVOKANA (Canagliflozin)

Last updated: November 5, 2025

Introduction

INVOKANA (canagliflozin) stands as a blockbuster pharmaceutical, developed by Janssen Pharmaceuticals—a Johnson & Johnson subsidiary—and approved by the FDA in 2013. It belongs to the SGLT2 (sodium-glucose co-transporter 2) inhibitor class, primarily prescribed for managing Type 2 Diabetes Mellitus (T2DM). Over the past decade, INVOKANA has navigated evolving market landscapes influenced by competitive dynamics, regulatory shifts, and expanding indications, shaping its financial trajectory and strategic positioning within the global diabetes care market.

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Market Landscape and Key Drivers

Global Diabetes Market and SGLT2 Inhibitors

The global T2DM market surpasses $80 billion annually, driven by rising prevalence, aging populations, and increasing adoption of oral antidiabetic agents.[1] SGLT2 inhibitors, introduced in the early 2010s, disrupted traditional glucose-lowering therapies through benefits like weight loss, blood pressure reduction, and cardio-renal protection. INVOKANA, as a pioneering agent, capitalized early on, experiencing rapid sales growth before facing competition from subsequent entrants like Jardiance (empagliflozin) and Farxiga (dapagliflozin).

Market Penetration and Adoption Dynamics

INVOKANA’s initial market penetration benefited from a comprehensive cardiovascular (CV) benefit profile, evidenced by the CANVAS program demonstrating CV risk reduction.[2] Cardiologists, nephrologists, and endocrinologists increasingly prescribed INVOKANA for not only glycemic control but also CKD and heart failure management, broadening its therapeutic scope. However, competition intensifies as newer SGLT2 inhibitors launch with similar or superior efficacy profiles and expanded indications.

Regulatory and Label Expansion

Regulatory advancements have shaped INVOKANA’s market profile. The FDA approved INVOKANA for CKD in 2021 based on the CREDENCE trial’s positive renal outcomes.[3] Additionally, the approval for heart failure with reduced ejection fraction (HFrEF) in 2022 exemplifies label expansion, bolstering sales prospects. These approvals have supported growth beyond diabetes, aligning INVOKANA with the broader cardiorenal therapeutic niche.

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Market Challenges and Competitive Dynamics

Safety Concerns and Regulatory Scrutiny

Safety issues have periodically dampened INVOKANA’s growth trajectory. Reports of increased risk of lower limb amputations, diabetic ketoacidosis, and genital infections have prompted warnings and label modifications.[4] The heightened safety monitoring has tempered some prescriber enthusiasm, especially in at-risk populations. Ongoing pharmacovigilance influences market perception and prescribing behavior, impacting sales.

Competitive Landscape

Jardiance and Farxiga have gained significant market share due to aggressive marketing, broader label indications, and similar efficacy. Jardiance, notably, demonstrated significant CV benefits in the EMPA-REG OUTCOME trial, positioning it as a preferred agent in certain settings.[5] The competition has prompted INVOKANA’s manufacturer to invest heavily in marketing, clinical studies, and label expansion strategies to maintain relevance.

Pricing Pressure and Cost-Containment

Payers and health systems are exerting pressure on drug prices amidst rising overall healthcare costs. The high costs of SGLT2 inhibitors have led to formulary restrictions and tier placement challenges, constraining sales growth. Consequently, Janssen has adopted value-based pricing models, providing rebates and negotiating discounts to sustain market share.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Since its launch, INVOKANA swiftly achieved blockbuster status with peak sales exceeding $1.2 billion globally in 2018.[6] Maintenance of revenue growth has become increasingly challenging amid intensified competition, safety alerts, and patent considerations.

Patent Expiry and Biosimilar Threats

Patent protection conferred to INVOKANA in key markets, such as the US and Europe, extends into the late 2020s. However, patent litigations and generic threats loom, especially as biosimilars or alternative agents could enter the market, pressuring pricing and margins. The expiration timeline varies across countries, with potential generic entry anticipated around 2028–2030.

Impact of Label Expansion on Revenue

The expansion into CKD and HFrEF markets offers new revenue streams, partially offsetting decline in diabetes-driven sales. However, these indications still constitute a smaller portion of the overall revenue mix. The real financial impact hinges on successful adoption by cardiologists and nephrologists and positive real-world data supporting efficacy.

Forecast and Strategic Outlook

Industry analysts project a gradual decline in INVOKANA’s diabetes sales beginning in the early 2030s due to patent expiry and competition.[7] Nonetheless, expanded indications could prolong its lifecycle and revenue streams. Janssen’s strategic focus involves investing in clinical trials, digital health integrations, and patient-centric programs to sustain and diversify INVOKANA’s portfolio.

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Market Opportunities and Strategic Initiatives

Expansion into New Indications

Beyond diabetes and renal indications, research into neurological and oncological applications for SGLT2 inhibitors opens future avenues. Janssen continues to explore such possibilities, potentially opening additional revenue streams.

Partnerships and Clinical Trials

Collaborations with academic institutions and healthcare providers aim to generate robust real-world evidence, demonstrating added value and improving prescriber confidence.

Digital Health and Patient Engagement

Digital health integrations facilitate remote monitoring and adherence, enhancing patient outcomes and demonstrating drug value, ultimately influencing formulary decisions.

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Regulatory and Reimbursement Considerations

Regulatory agencies continue to evaluate the long-term safety and efficacy of INVOKANA. The evolving landscape necessitates adaptive strategies, including proactive safety monitoring and real-world evidence generation.

Reimbursement policies increasingly favor value-based agreements, with payers emphasizing outcomes over volume. Janssen’s ability to demonstrate clinical and economic benefits is pivotal to securing favorable formulary positions.

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Key Takeaways

• Market Position: INVOKANA remains a key player in the SGLT2 inhibitor class, with expanded indications bolstering its clinical relevance amid rising competition.

• Revenue Trajectory: Peak sales in the late 2010s position INVOKANA as a blockbuster; however, patent expiration and biosimilar entries forecast revenue declines starting in the early 2030s.

• Competitive Strategy: Differentiation through label expansion, safety management, and real-world evidence is essential to maintain market share.

• Market Challenges: Safety concerns, pricing pressure, and patent cliffs pose ongoing threats, demanding adaptive strategic responses.

• Future Outlook: Continued investment in clinical research, digital health, and expanding indications will be critical to extend INVOKANA’s lifecycle and sustain its financial performance.

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FAQs

1. What are the main therapeutic benefits of INVOKANA?
INVOKANA offers effective glycemic control in T2DM, along with additional benefits such as weight loss, blood pressure reduction, and proven cardiovascular and renal protection.

2. How has safety concerns impacted INVOKANA’s market presence?
Safety alerts regarding amputations, ketoacidosis, and infections have prompted caution among prescribers, influenced labeling, and moderated sales growth.

3. What are the key factors influencing INVOKANA’s future revenue?
Patent expiration, competitive dynamics, label expansions, safety perceptions, and payer reimbursement policies significantly influence future sales.

4. How does INVOKANA compare to other SGLT2 inhibitors?
While similarly efficacious, INVOKANA faces stiff competition from agents like Jardiance and Farxiga, which have garnered pharmacovigilance advantages and broader indications.

5. What strategic moves can Janssen undertake to sustain INVOKANA’s market position?
Investing in additional clinical trials, expanding labels, engaging in digital health innovation, and demonstrating cost-effectiveness will be crucial strategies.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 9th Edition, 2019.
2. Neal B, Perkovic V, Mahaffey KW et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017;377(7):644-657.
3. US Food and Drug Administration. FDA approves canagliflozin for treatment of chronic kidney disease. 2021.
4. US FDA. Safety Labels for INVOKANA. 2018.
5. Zinman B, Wanner C, Fitchett D et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015;373(22):2117-2128.
6. Johnson & Johnson. Annual Reports and Press Releases, 2018–2022.
7. MarketWatch. SGLT2 Inhibitors Market Forecast, 2023–2035.

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