Canagliflozin - Generic Drug Details

What are the generic drug 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:

7,943,582*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
McGill University Health Centre/Research Institute of the McGill University Health Centre	PHASE2
Canadian Institutes of Health Research (CIHR)	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	204353-002	Aug 8, 2014		RX	Yes	No
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-002	Aug 8, 2014		RX	Yes	No
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No	7,943,788*PED				Y

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
Mexico	2009005857
Taiwan	200521131	Substituted fused heterocyclic c-glycosides
Netherlands	300670
Canada	2549015	C-GLYCOSIDES HETEROCYCLIQUES FUSIONNES SUBSTITUES (SUBSTITUTED FUSED HETEROCYCLIC C-GLYCOSIDES)

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	164 1-2014	Slovakia		PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658	C20140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	92426	Luxembourg		PRODUCT NAME: CANAGLIFLOZINE

Market Dynamics and Financial Trajectory for CANAGLIFLOZIN

Last updated: March 4, 2026

What is the market size and growth potential for CANAGLIFLOZIN?

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor approved for type 2 diabetes mellitus (T2DM). It was approved by the FDA in 2013 and marketed by Johnson & Johnson under the Invokana brand. The global SGLT2 inhibitor market reached approximately USD 8.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 12.7% from 2023 to 2028. Canagliflozin holds roughly 38% of this market, behind competing drugs like dapagliflozin and empagliflozin.

Regional market breakdown (2022):

Region	Market Size (USD billion)	Market Share (%)
North America	4.1	50
Europe	2.0	24
Asia-Pacific	1.4	17
Rest of World	0.7	9

Growth drivers:

• Increasing prevalence of T2DM worldwide, projected to reach 700 million cases by 2045 [1].
• Adoption of SGLT2 inhibitors for cardiovascular and renal benefits.
• Expanding indications to include heart failure and chronic kidney disease.

Challenges:

• Market saturation among early adopters.
• Patent expiration risks potentially leading to generics.
• Competitive landscape with newer SGLT2 inhibitors and combination therapies.

How is Canagliflozin performing financially?

Johnson & Johnson reported peak sales of USD 1.6 billion in 2018 for Invokana. Sales declined modestly afterward due to patent cliffs and increased generic competition. For the fiscal year 2022, Invokana sales were approximately USD 800 million, representing a 7.5% year-over-year decline [2].

Revenue breakdown:

Year	Sales (USD million)	Change (%)
2018	1,600	—
2019	1,480	-7.5
2020	1,250	-15.5
2021	900	-28
2022	800	-11.1

Profitability:

• Gross margins for Invokana are approximately 70%.
• R&D expenses related to further indications or combination formulations are estimated at USD 150 million annually.

What is the competitive landscape?

Company	Product	Market Share	Key Features
Johnson & Johnson	Canagliflozin (Invokana)	38%	First approved SGLT2 inhibitor, cardiovascular and renal benefits
AstraZeneca	Dapagliflozin (Farxiga)	30%	Strong CV and renal data, expanding indications
Boehringer Ingelheim	Empagliflozin (Jardiance)	22%	Superior cardiovascular outcomes, multiple formulations
Others	-	10%	Various generics and regional players

Patent expiration for Invokana is expected by 2026 in key markets, which may open opportunities for generics and biosimilars.

What are the key regulatory and policy influences?

Regulatory agencies increasingly approve drugs with demonstrated cardiovascular and renal benefits, which favors SGLT2 inhibitors like canagliflozin [3]. Stricter patent protections and pricing policies influence market access and profitability.

In 2021, the FDA approved label extensions for additional indications, including heart failure with reduced ejection fraction (HFrEF). These extensions could expand the drug’s addressable patient population, impacting sales positively.

What are the strategic considerations for Canagliflozin's commercial trajectory?

• Generic Competition: Anticipated patent cliffs around 2026 may reduce revenue sharply unless products are biosimilar.
• Line Extensions: Developing fixed-dose combinations (e.g., with metformin) and new delivery systems could sustain revenue.
• New Indications: Expanding clinical trials into heart failure and chronic kidney disease may open new markets.
• Regional Expansion: Focusing on emerging markets with rising T2DM prevalence can boost sales.

Summary of financial outlook

Scenario	Assumptions	Potential Revenue Outlook
Base case	Patent expiry in 2026, moderate market share decline	USD 400-600 million from 2027 onward
Optimistic case	Successful label extensions, minimal generic impact	USD 800-1.2 billion by 2030
Pessimistic case	Rapid generic erosion, limited new indications	USD 0.2-0.4 billion post-2026

Key takeaways

• Canagliflozin commands a significant share of the SGLT2 market, but faces patent expiration by 2026.
• Growth depends on expanding indications, formulation enhancements, and regional penetration.
• Competitive pressures from dapagliflozin and empagliflozin are intensifying.
• Revenue decline is probable post-patent expiration, unless offset by new indications or combination therapies.
• Market size is driven by the global rise in T2DM cases and secondary indications like heart failure and renal disease.

FAQs

Q1: When are patents for Canagliflozin expected to expire?
A1: Patents are expected to expire in 2026 in major markets like the U.S. and Europe.

Q2: How does Canagliflozin compare to other SGLT2 inhibitors?
A2: It was the first approved and has significant cardiovascular and renal data. Competitors like dapagliflozin and empagliflozin rival it in efficacy and safety profiles.

Q3: What are the opportunities for Canagliflozin after patent expiration?
A3: Opportunities include development of biosimilars, new formulations, and new indications that could sustain revenues.

Q4: Which regions present the most growth opportunities?
A4: Asia-Pacific and Latin America exhibit the highest incidence of T2DM growth, representing major expansion potential.

Q5: How are regulatory policies affecting Canagliflozin's market?
A5: Increased focus on cardiovascular and renal benefits has facilitated label extensions; however, pricing pressures and patent protections impact profitability.

References

1. International Diabetes Federation. (2022). Diabetes Atlas 10th Edition.
2. Johnson & Johnson. (2022). Annual Report 2022.
3. U.S. Food and Drug Administration. (2021). Label Updates for SGLT2 Inhibitors.