Canagliflozin - Generic Drug Details

What are the generic sources for canagliflozin and what is the scope of freedom to operate?

Canagliflozin is the generic ingredient in three branded drugs marketed by Janssen Pharms and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are twenty-one drug master file entries for canagliflozin. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for canagliflozin

International Patents:	220
US Patents:	4
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	154
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for canagliflozin
What excipients (inactive ingredients) are in canagliflozin?	canagliflozin excipients list
DailyMed Link:	canagliflozin at DailyMed

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

Constraining patent/regulatory exclusivity:

7,943,788*PED

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 canagliflozin

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	PHASE2
McGill University Health Centre/Research Institute of the McGill University Health Centre	PHASE2
West China Hospital	PHASE1

See all canagliflozin clinical trials

Generic filers with tentative approvals for CANAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET; ORAL
		300mg	TABLET; ORAL
		300MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for canagliflozin

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

Medical Subject Heading (MeSH) Categories for canagliflozin

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for canagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for CANAGLIFLOZIN

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 canagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014		RX	Yes	No	8,513,202*PED				Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No	11,576,894		Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014		RX	Yes	No	11,576,894		Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No	8,513,202*PED				Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No

EU/EMA Drug Approvals for canagliflozin

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 canagliflozin

Country	Patent Number	Title	Estimated Expiration
Israel	173050	GLUCOPYRANOSYL DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME AND USES THEREOF
New Zealand	577545	CRYSTALLINE FORM OF 1- (BETA-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL] BENZENE HEMIHYDRATE
Guatemala	200900151
Eurasian Patent Organization	010299	НОВЫЕ СОЕДИНЕНИЯ, ОБЛАДАЮЩИЕ ИНГИБИРУЮЩЕЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ НАТРИЙЗАВИСИМОГО ТРАНСПОРТЁРА (NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDANT TRANSPORTER)
European Patent Office	1680414	INDAZOLES- GLUCOSIDES SUBSTITUES (SUBSTITUTED INDAZOLE-O-GLUCOSIDES)

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658	14C0034	France		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	PA2014008	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	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
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

Market Dynamics and Financial Trajectory for Canagliflozin

Last updated: April 22, 2026

Canagliflozin, marketed as Invokana, is an SGLT2 inhibitor indicated primarily for type 2 diabetes management. Its market position, growth drivers, competitive landscape, and revenue forecasts reflect its evolving role within diabetes treatment and related indications.

Market Entry and Regulatory Status

Canagliflozin received FDA approval in March 2013. It was the first SGLT2 inhibitor approved in the United States, followed by approvals in Europe (2014) and other markets.

In 2017, the FDA issued a boxed warning for increased amputation risk, leading to market hesitations. The safety profile remains under regulatory surveillance, influencing prescribing patterns.

Market Size and Growth Drivers

The global SGLT2 inhibitor market was valued at approximately USD 10 billion in 2022. Projected compound annual growth rate (CAGR) from 2023 to 2030 stands around 12%. This growth reflects:

• Increased adoption for type 2 diabetes treatment.
• Expansion into heart failure and chronic kidney disease (CKD) indications, where SGLT2 inhibitors show cardiovascular and renal benefits.
• Rising prevalence of type 2 diabetes, projected to reach 700 million cases by 2045, per IDF[1].

Revenue and Sales Analytics

Canagliflozin's sales have displayed variability, influenced by safety warnings and competitive pressures. A snapshot:

Year	Global Sales (USD millions)	Year-over-Year Growth
2019	1,200	-
2020	1,400	16.7%
2021	1,650	17.9%
2022	1,850	12.1%

In 2022, Pfizer (which markets Invokana) reported global revenues of USD 3.8 billion for the SGLT2 inhibitor portfolio, with canagliflozin accounting for roughly half of the segment, adjusted for market factors[2].

Competitive Landscape

Canagliflozin faces competition from newer agents:

• Dapagliflozin (Farxiga, Dexcom): Launched in 2014, with expanding indications.
• Empagliflozin (Jardiance): Launched in 2014, recognized for cardiovascular benefits.
• Ertugliflozin (Steglatro): Approved in 2017, with a smaller market share.

Market share distribution (2022):

Drug	Estimated Market Share	Unique Indications
Dapagliflozin	35%	Heart failure, CKD
Empagliflozin	30%	Heart failure, CV risk reduction
Canagliflozin	20%	Diabetes, CKD (expanded)
Others	15%	Emerging agents

Key Market Expansion and Revenue Drivers

• Expanded indications for heart failure and CKD treatments boost usage.
• Efficacy profile and safety improvements via dose adjustments impact adoption.
• Patent exclusivity expires in the mid-2020s, opening the path for generic competition, which could depress prices.

Financial Forecasts

Analysts project the following trends:

• Revenue from canagliflozin could decline by 5–10% annually starting in 2026 due to patent expiry and generic competition.
• Peak sales are estimated around USD 2.5 billion by 2024.
• Post-patent expiration, generic versions could reduce market prices by approximately 60%, significantly reshaping margins and sales volume.

Regulatory and Pricing Policies

Pricing strategies are influenced by healthcare policies, especially in the US and Europe:

• US Medicare and Medicaid negotiations aim to control costs, pressuring list prices.
• European price controls tend to limit reimbursement levels, constraining revenue growth.

Risks and Opportunities

• Safety concerns, particularly cardiovascular and amputation risks, impact market share.
• Ongoing trials exploring broader indications, such as non-diabetic CKD, offer future opportunities.
• Market competition from innovative SGLT2 inhibitors and non-SGLT2 diabetes drugs threatens market dominance.

Key Takeaways

• Canagliflozin holds approximately a 20% share of the global SGLT2 inhibitor market.
• Revenue peaked around USD 1.85 billion in 2022 with growth driven by expanded indications.
• Patent expiration in mid-2020s poses a significant risk for revenue decline due to generic entry.
• Competitive landscape is intensifying; newer agents integrate broader indications with improved safety profiles.
• Regulatory scrutiny, safety warnings, and pricing policies influence future revenue trajectories.

FAQs

1. When will generic canagliflozin enter the market?
Patent expiry is expected around 2025–2026, after which generic versions could reduce brand revenue significantly.

2. How do safety concerns affect canagliflozin sales?
Safety issues, especially increased amputation risk, led to caution among clinicians, marginally reducing prescriptions and market share.

3. What are the primary indications for canagliflozin?
Type 2 diabetes, with expanding use in CKD and heart failure based on recent trial data.

4. Which markets dominate the sales of canagliflozin?
The US accounts for approximately 50% of sales, followed by Europe and other regions.

5. What is the outlook for canagliflozin’s revenue after patent expiration?
Revenues are expected to decline, potentially by 50% or more within two years of generic launch, depending on market penetration and price discounting.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas (10th ed.).
[2] Pfizer Inc. (2023). Annual Report 2022.