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 seven 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 sixty-eight patent family members in forty-seven 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:	268
US Patents:	7
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	144
Patent Applications:	355
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:

10,617,668

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
Heart and Stroke Foundation of Canada	Phase 2
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 2
Ain Shams University	Phase 1/Phase 2

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 XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	8,785,403		Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	8,513,202		Y	Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes	7,943,582		Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No	7,943,788		Y	Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes	11,576,894		Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No	8,785,403		Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No	7,943,788		Y	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/002649 Invokana 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
Hong Kong	1086277	NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDANT TRANSPORTER
Australia	2004260761	Novel compounds having inhibitory activity against sodium-dependant transporter
Taiwan	I365186
Eurasian Patent Organization	015104	НОВЫЕ СОЕДИНЕНИЯ, ОБЛАДАЮЩИЕ ИНГИБИРУЮЩЕЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ НАТРИЙЗАВИСИМОГО ТРАНСПОРТЕРА (NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDANT TRANSPORTER)
World Intellectual Property Organization (WIPO)	2006080577
Ukraine	83377	N-ГЛИКОЗИД, СПОСОБ ЕГО ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ;N-ГЛІКОЗИД, СПОСІБ ЙОГО ОДЕРЖАННЯ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ТА СПОСІБ ЛІКУВАННЯ (N- GLYCOSIDE, PROCESS FOR THE PREPARATION THEREOF, PHARMACEUTICAL COMPOSITION AND TREATMENT METHOD)
Cyprus	1118093

Supplementary Protection Certificates for canagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	C01651658/01	Switzerland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658	2014C/027	Belgium		PRODUCT NAME: CANAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/13/884 20131119
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658	29/2014	Austria		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
1651658	637	Finland
1651658	92426	Luxembourg		PRODUCT NAME: CANAGLIFLOZINE
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119

Canagliflozin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Canagliflozin

Market Overview

Canagliflozin, along with other SGLT2 inhibitors like empagliflozin and dapagliflozin, is a crucial component in the treatment of type 2 diabetes and related cardiovascular conditions. Here’s a detailed look at the market dynamics and financial trajectory of canagliflozin.

Market Size and Growth

The global market for empagliflozin, dapagliflozin, and canagliflozin is experiencing steady growth. In 2023, the market size was valued at $9.41 billion and is expected to reach $9.64 billion in 2024, growing at a compound annual growth rate (CAGR) of 2.4%[1].

By 2028, the market is projected to grow to $10.78 billion at a CAGR of 2.8%, driven by increasing demand for oral diabetes medications, investments in diabetes research, and rising healthcare expenditure[1].

On a broader scale, the gliflozin market, which includes canagliflozin, is expected to reach $15.5 billion by 2032, growing at a CAGR of 12.9%[3].

Drivers of the Market

Several factors are driving the growth of the canagliflozin market:

• Increasing Prevalence of Type 2 Diabetes: The global incidence of type 2 diabetes is rising, with approximately 537 million adults affected in 2023, expected to increase to 643 million by 2030. This surge is driven by dietary changes, sedentary lifestyles, and increased obesity rates[4].
• Awareness and Benefits of SGLT2 Inhibitors: There is growing recognition of the glycemic control and cardiovascular protection benefits of SGLT2 inhibitors like canagliflozin, which is driving their adoption[4].
• Aging Population: The growth in the elderly population is another significant driver, as this demographic is more prone to diabetes and related complications[1].
• Focus on Personalized Medicine: Increasing focus on personalized medicine and combination therapies is also contributing to the market growth[1].

Cost-Effectiveness

Canagliflozin has been shown to be a cost-effective treatment option compared to other SGLT2 inhibitors like dapagliflozin. A study from the perspective of Chinese healthcare service providers found that canagliflozin 100 mg was associated with additional life years and quality-adjusted life years (QALYs) at a lower total mean cost compared to dapagliflozin 10 mg. The incremental cost of canagliflozin 100 mg versus dapagliflozin 10 mg was $-129, indicating that canagliflozin was a dominant and cost-saving option[2][5].

Base-Case Outcomes

• Health Benefits: Canagliflozin 100 mg gained an average of 0.015 life years and 0.013 QALYs per patient treated compared to dapagliflozin 10 mg.
• Cost Savings: The strategy with canagliflozin 100 mg resulted in lower total mean costs over a patient’s lifetime, with an incremental cost-effectiveness ratio (ICER) of $-9,781 per QALY gained[2].

Sensitivity Analysis

Sensitivity analyses revealed that the results were sensitive to the costs of canagliflozin and dapagliflozin, with the cost of canagliflozin having a substantial impact on the economic outcomes. However, the base-case results were relatively robust to adjustments in input variables and assumptions[2].

Regional Analysis

The market for canagliflozin varies significantly across different regions:

• North America: Supported by sophisticated healthcare systems, significant research and development, and a high prevalence of type 2 diabetes due to lifestyle factors[4].
• Asia Pacific: This region is seeing rapid growth due to increasing healthcare expenditure and a large population with diabetes. China, in particular, has seen a significant financial burden from diabetes, which is driving the adoption of cost-effective treatments like canagliflozin[5].
• Europe and Other Regions: Each region has its unique factors, including regulatory frameworks, healthcare infrastructure, and market penetration of SGLT2 inhibitors[4].

Distribution Channels

The distribution of canagliflozin is primarily through:

• Hospital Pharmacies: A significant channel due to the need for prescription and monitoring.
• Retail Pharmacies: Also a major channel, especially for patients with stable conditions.
• Online Pharmacies: Growing in importance due to convenience and accessibility[3].

Technological Advancements and Trends

Several trends are shaping the market for canagliflozin:

• Combination Therapies: Increasing focus on combination therapies to enhance treatment outcomes.
• Telehealth: The integration of telehealth services is improving patient access and monitoring.
• Health Data Analytics: The use of health data analytics to personalize treatment plans and monitor patient outcomes.
• Patient Data Security: Ensuring the security of patient data is a critical trend, especially with the increasing use of digital health services[1].

Key Takeaways

• Canagliflozin is part of a growing market for SGLT2 inhibitors, driven by the increasing prevalence of type 2 diabetes and awareness of its benefits.
• It has been shown to be a cost-effective treatment option compared to dapagliflozin.
• Regional market dynamics vary, with North America and Asia Pacific being key regions.
• Distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies.
• Technological advancements such as telehealth, health data analytics, and patient data security are shaping the market.

FAQs

What is the current market size for canagliflozin and other SGLT2 inhibitors?

The global market for empagliflozin, dapagliflozin, and canagliflozin was valued at $9.41 billion in 2023 and is expected to reach $9.64 billion in 2024[1].

How cost-effective is canagliflozin compared to dapagliflozin?

Canagliflozin 100 mg has been shown to be a cost-saving treatment option compared to dapagliflozin 10 mg, with an incremental cost of $-129 and additional health benefits in terms of life years and QALYs[2].

What are the main drivers of the canagliflozin market?

The main drivers include the increasing prevalence of type 2 diabetes, growing awareness of the benefits of SGLT2 inhibitors, an aging population, and a focus on personalized medicine[1][4].

Which regions are key for the canagliflozin market?

North America and the Asia Pacific are significant regions due to their healthcare infrastructure, prevalence of diabetes, and regulatory frameworks[4].

How is the distribution of canagliflozin changing?

The distribution is increasingly through hospital pharmacies, retail pharmacies, and online pharmacies, with a growing emphasis on convenience and accessibility[3].

What technological trends are impacting the canagliflozin market?

Trends include combination therapies, telehealth, health data analytics, and patient data security, all of which are enhancing treatment outcomes and patient care[1].

Sources

1. The Business Research Company: Empagliflozin, Dapagliflozin And Canagliflozin Global Market Report 2024.
2. Frontiers in Pharmacology: Cost-Effectiveness of Canagliflozin Versus Dapagliflozin Added to Metformin in Patients with Type 2 Diabetes Mellitus.
3. Market Research Future: Gliflozin Market Size, Trends, Growth Report 2032.
4. Verified Market Research: Empagliflozin Dapagliflozin And Canagliflozin Market Size, Scope.
5. Frontiers in Pharmacology: Cost-Effectiveness of Canagliflozin Versus Dapagliflozin Added to Metformin in Patients with Type 2 Diabetes Mellitus (PDF).