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 five 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:	5
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

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	204353-004	Aug 8, 2014		RX	Yes	Yes					Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes					Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No					Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	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
Uruguay	30730	FORMA CRISTALINA DEL HEMIHIDRATO DE 1-(B (BETA)-D-GLUCOPIRANOSIL) -4-METIL-3-[5-(4-FLUOROFENIL) -2-TIENILMETIL]BENCENO
Taiwan	200829259	Crystalline form of 1-(&bgr;-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate
Spain	2531660
Eurasian Patent Organization	200600348	НОВЫЕ СОЕДИНЕНИЯ

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	29/2014	Austria		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658	C01651658/01	Switzerland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658	300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118

Market Dynamics and Financial Trajectory for Canagliflozin

Last updated: July 27, 2025

Introduction

Canagliflozin, marketed as Invokana among other brands, is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated primarily for the management of type 2 diabetes mellitus (T2DM). Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, canagliflozin has become a significant segment of the diabetes treatment landscape, contributing to its pharmaceutical manufacturers' revenue streams and influencing broader market trends in metabolic disorders. This article analyzes current market dynamics and forecasts the financial trajectory for canagliflozin, emphasizing competitive positioning, regulatory factors, market demand, and technological innovation.

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Market Landscape and Competitive Environment

Market Penetration and Adoption Trends

Canagliflozin has benefited from the rising prevalence of T2DM globally, projected to reach 700 million adults by 2045 according to the International Diabetes Federation (IDF) [1]. Its mechanism as an SGLT2 inhibitor offers advantages such as weight loss and blood pressure reduction—attributes increasingly valued in multi-morbidity patient profiles—bolstering its adoption.

In the U.S., Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) initially held a dominant market share following FDA approval. However, as newer SGLT2 inhibitors entered the market — including dapagliflozin (Farxiga/Forxiga) and empagliflozin (Jardiance) — competition intensified. The emergence of these alternatives has prompted Janssen to innovate and expand indications, while generic pipelines remain limited due to patent protections.

Market Share Dynamics

Despite competitive pressure, canagliflozin maintains a significant share due to its early market entry, clinical backing, and established reimbursement pathways. However, recent market reports suggest a gradual shift, with Jardiance and other SGLT2 inhibitors gaining ground, especially given evidence of added cardiovascular and renal benefits [2].

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Regulatory Factors and Patent Landscape

Patent Expiry and Generic Competition

Canagliflozin’s primary patents are set to expire between 2025 and 2028 across key markets, potentially opening opportunities for biosimilar or generic entrants that could erode sales. The patent landscape remains complex, with ongoing legal battles and secondary patents attempting to extend exclusivity. Such factors heavily influence market stability and pricing strategies.

Regulatory Approvals and Expansions

Beyond initial indications for T2DM, regulatory agencies have approved canagliflozin for diabetic nephropathy and reduce risk of cardiovascular events. Expansion into these indications broadens the addressable patient population, positively impacting revenue projections.

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Market Drivers and Challenges

Growth Catalysts

• Increasing Prevalence of T2DM: The ongoing global surge in type 2 diabetes is the primary driver, amplifying demand.
• Cardiovascular and Renal Benefits: Clinical trials such as CANVAS (Canagliflozin Cardiovascular Assessment Study) demonstrated cardiovascular hazard reduction, fostering broader acceptance among clinicians.
• Combination Therapy: Canagliflozin’s compatibility with other antidiabetic agents makes it adaptable within combination regimens, elevating its utility.

Market Challenges

• Safety Profile Concerns: Risks like ketoacidosis, urinary tract infections, and amputations have cast a shadow over the class. The FDA issued a label warning regarding amputation risk in 2017, impacting prescribing patterns.
• Pricing Pressures: As patent expiration approaches, cost competition could result in price erosion.
• Physician and Patient Preferences: Preference for newer agents with broader cardiovascular data or different side-effect profiles influences uptake.

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Financial Trajectory and Revenue Forecasts

Historical Financial Performance

Janssen reports that canagliflozin generated approximately \$700 million in global sales during 2020, with steady annual growth prior to patent expiration concerns. The drug’s revenue is driven by expanding indications, increased global prescriptions, and formulary access.

Projected Market Forecasts

Analysts project that the global SGLT2 inhibitor market will grow at a compounded annual growth rate (CAGR) of roughly 15% from 2022 to 2028, reaching upwards of \$30 billion. Canagliflozin is expected to capture a significant share due to its early position, although growth may plateau as newer agents and biosimilars enter.

Impact of Patent Expiry

Given patent expirations between 2025-2028, potential revenue declines are anticipated unless the manufacturer diversifies through biosimilar launches, indications expansion, or formulation innovations. A strategic focus on renal and cardiovascular indications could mitigate revenue erosion and sustain growth longer-term.

Company Strategies

Janssen’s approaches include:

• Line Extensions: Developing fixed-dose combinations to enhance adherence.
• New Indications: Seeking approvals for heart failure and kidney diseases.
• Cost Management: Adapting manufacturing and distribution efficiencies in anticipation of biosimilar entry.

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Emerging Trends and Innovations

Next-Generation SGLT2 Inhibitors

Research focuses on developing SGLT2 inhibitors with improved safety profiles, higher selectivity, and additional mechanisms. Such advancements could modify the competitive landscape, impacting canagliflozin’s financial trajectory.

Digital Health Integration

Incorporating real-world data and digital therapeutics may facilitate better patient management, driving adherence and prescriptions.

Market Expansion into Emerging Economies

Growing healthcare infrastructure in Asia and Africa offers substantial opportunities, albeit with pricing and access challenges.

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Conclusion

Canagliflozin’s market dynamics are shaped by its early entry, expanding indications, and the escalating prevalence of T2DM globally. While facing increasing competition and impending patent challenges, strategic diversification into cardiovascular and renal indications sustains its revenue trajectory. The financial outlook remains cautiously optimistic; however, patent cliffs and competitive pressures necessitate innovation, market expansion, and cost management to preserve profitability.

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Key Takeaways

• Canagliflozin remains a significant player in the SGLT2 inhibitor market, supported by clinical benefits and expanding indications.
• Patent expirations from 2025 onward threaten future revenues, emphasizing the importance of biosimilars and line extensions.
• Market growth is driven by diabetes prevalence, cardiovascular benefits, and combination therapies; challenges include safety concerns and pricing pressures.
• Strategic investments in indications beyond T2DM, such as renal and heart failure, are crucial for revenue sustainment.
• The evolving competitive landscape underscores the need for continuous innovation and market adaptation.

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FAQs

1. What are the main competitors to canagliflozin in the SGLT2 inhibitor class?
Dapagliflozin (Farxiga/Forxiga), empagliflozin (Jardiance), and ertugliflozin (Steglatro) are primary competitors, each with distinct clinical data and global market penetration strategies [2].

2. How do safety concerns impact the market for canagliflozin?
Safety issues like amputation risk and diabetic ketoacidosis have led to cautious prescribing and label warnings, potentially affecting sales and market share.

3. When are key patents for canagliflozin set to expire?
Patent protection is expected to expire between 2025 and 2028 in major markets, prompting industry anticipation of biosimilar entry.

4. What strategies can the manufacturer employ to maintain profitability post-patent expiry?
Investing in line extensions, expanding indications (e.g., heart failure, kidney disease), and developing biosimilars are key strategies.

5. What role will emerging markets play in the future sales of canagliflozin?
Growing diabetes prevalence and expanding healthcare infrastructure in emerging economies offer significant revenue opportunities, provided affordability and access are addressed.

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References

[1] International Diabetes Federation. "IDF Diabetes Atlas, 9th Edition," 2019.
[2] American Diabetes Association. "Standards of Medical Care in Diabetes—2022," Diabetes Care, 2022.