CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

What are the generic sources for canagliflozin; metformin hydrochloride and what is the scope of patent protection?

Canagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Janssen Pharms and is included in two 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; metformin hydrochloride has two hundred and seventy-one patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

International Patents:	271
US Patents:	5
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	53
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

7,943,582*PED

Dosage:

TABLET, EXTENDED RELEASE;ORAL

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; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Oman Ministry of Health	PHASE4
Ping Li,MD	PHASE4
Ain Shams University	Phase 1/Phase 2

See all CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVOKAMET XR	Extended-release Tablets	canagliflozin; metformin hydrochloride	50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg	205879	1	2018-11-21
INVOKAMET	Tablets	canagliflozin; metformin hydrochloride	50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg	204353	6	2017-03-29

US Patents and Regulatory Information for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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	8,513,202*PED				Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No	8,222,219*PED				Y

Expired US Patents for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016	6,723,340
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016	8,785,403
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016	8,785,403

International Patents for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Colombia	6210719
South Africa	200603879	Substituted indazole-O-glucosides
World Intellectual Property Organization (WIPO)	2006080577

Supplementary Protection Certificates for CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	637	Finland
1651658	C20140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013

Market Dynamics and Financial Trajectory for CANAGLIFLOZIN and METFORMIN HYDROCHLORIDE

Last updated: July 28, 2025

Introduction

The global pharmaceutical landscape for type 2 diabetes management continues to evolve driven by advancements in medication efficacy, regulatory policies, aging populations, and increasing prevalence of diabetes. Among key pharmacological agents, Canagliflozin, an SGLT2 inhibitor, and Metformin Hydrochloride, a longstanding first-line therapy, underpin a significant segment of this market. This analysis explores the current market dynamics, growth trajectories, competitive landscape, and future outlook for these two drugs, providing insights critical for stakeholders.

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Market Overview

Metformin Hydrochloride

Introduced in the 1950s, Metformin remains the most prescribed oral antidiabetic agent globally. Its robust efficacy, safety profile, low cost, and extensive clinical evidence underpin its status as the first-line therapy for type 2 diabetes [1].

The metformin market benefits from high global penetration, with over 120 million prescriptions annually worldwide [2]. Its widespread use is reinforced by recommendations from major guidelines such as the American Diabetes Association (ADA), which continues to endorse it as the initial pharmacological intervention.

Canagliflozin

Approved by the U.S. Food and Drug Administration (FDA) in 2013, Canagliflozin is an SGLT2 inhibitor that promotes urinary glucose excretion, yielding glycemic control and additional benefits such as weight loss and blood pressure reduction [3].

Initially produced by Janssen Pharmaceuticals, Canagliflozin gained rapid market penetration owing to its novel mechanism, cardiovascular benefits demonstrated in clinical trials, and expanding indications including diabetic kidney disease [4]. Despite competition from other SGLT2 inhibitors such as Dapagliflozin and Empagliflozin, Canagliflozin maintained a significant market share owing to robust efficacy data.

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Market Dynamics

Drivers

• Rising Prevalence of Type 2 Diabetes: An estimated 537 million adults worldwide had diabetes as of 2021, with projections reaching 700 million by 2045 [5]. This surge directly amplifies demand for both established and novel therapies.

• Shift Towards Personalized Medicine: A focus on tailored treatment regimens, leveraging clinical trials demonstrating cardiovascular and renal benefits (notably with SGLT2 inhibitors), has expanded the therapeutic scope.

• Regulatory Endorsements and Label Expansions: The inclusion of cardiovascular and renal outcomes in drug labeling has driven market growth, especially for agents like Canagliflozin.

• Cost-Effectiveness of Metformin: Its low-cost profile facilitates high adoption, especially in emerging markets, sustaining its market dominance.

Challenges

• Side Effect Profiles: Concerns over potential adverse effects such as lactic acidosis in metformin or genital infections with SGLT2 inhibitors have impacted prescriber decisions.

• Generic Competition: The availability of generic metformin compresses prices and margins for branded formulations.

• Regulatory and Patent Dynamics: Patent expirations for Canagliflozin in some jurisdictions, such as the US in 2024, threaten revenue streams, encouraging generic developments.

Market Volatility and Competition

The emergence of multiple SGLT2 inhibitors injects competitive pressure, impacting the pricing and market share of Canagliflozin. Simultaneously, the widespread use of metformin, coupled with its pending patent expiry, challenges branded formulations' profitability. Biopharmaceutical companies are investing in combination therapies, with fixed-dose combinations (FDCs) such as metformin with SGLT2 inhibitors gaining popularity.

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Financial Trajectory and Market Projections

Historical Performance

• Metformin: The oldest, with a well-established market, has maintained consistent growth. Global sales exceeded USD 1.5 billion annually as of 2021 [6]. Its affordability and extensive clinical evidence foster sustained demand.

• Canagliflozin: Estimated global sales peaked near USD 2.1 billion in 2019, accounting for approximately 65% of the SGLT2 class sales [7]. Growth was driven by expanding indications and cardiovascular benefits.

Forecasted Growth Trends

Metformin

The market for metformin is projected to plateau or decline marginally in mature economies due to generic competition but will remain significant in emerging markets owing to affordability. The global market is expected to sustain a compounded annual growth rate (CAGR) of approximately 2-3% through 2028, primarily driven by population growth.

Canagliflozin

The SGLT2 inhibitor segment, led by Canagliflozin, is anticipated to grow at a CAGR of 8-10% from 2021 to 2028. Factors influencing this projected growth include:

• Expansion of Indications: Approvals for heart failure and chronic kidney disease widen usage.

• Increased Adoption: Prescriber confidence influenced by positive outcome trials (e.g., CANVAS, CREDENCE).

• Market Penetration in Emerging Economies: Although slower due to cost constraints, initiatives to improve access are progressing.

• Patent Dynamics: The imminent patent expiry of Canagliflozin in select markets may temporarily inhibit revenue growth until generic competition matures. However, biosimilars and generics are anticipated to enter the market within the next 1-2 years, exerting downward pressure on prices.

Revenue and Profitability Trends

The revenue trajectory of Canagliflozin is expected to decline post-patent expiration unless offset by increased volume or expanded indications. Nonetheless, investments in combination therapies and novel indications may catalyze new revenue streams.

In contrast, metformin's revenue will likely stabilize, supported by volume and affordability advantages in both developed and developing markets.

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Regulatory and Market Influences

• Regulatory Approvals: The affirmation of cardiovascular and renal benefits by agencies like the FDA and EMA enhances confidence and adoption, especially for Canagliflozin. Conversely, safety concerns or side effect profiles may lead to revisits of labeling.

• Pricing and Reimbursement Policies: Governments and insurers influence drug accessibility. Price controls in certain regions may suppress sales growth but also stimulate generics.

• Patient-Centric Innovations: Combination FDCs and sustained-release formulations improve adherence and can stimulate incremental sales.

• Generic Competition: The expiration of Canagliflozin patents will democratize access but may impair profitability and market share stability for brand manufacturers.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: To sustain revenue, focus on expanding indications, investing in combination therapies, and preempting patent cliffs with pipeline diversification.

• Investors: Monitor regulatory developments, patent statuses, and real-world evidence that influence market access and pricing.

• Healthcare Providers: Evaluate emerging evidence supporting cardiovascular and renal benefits, adjusting prescribing patterns accordingly.

• Policy Makers: Support access innovations while balancing affordability and incentivizing R&D.

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Key Takeaways

• Market dominance: Metformin continues its global relevance due to low cost and efficacy, with a steady but mature growth trajectory.

• Growth potential: Canagliflozin is positioned for robust growth driven by expanded indications, improved clinical outcomes, and ongoing market penetration, though vulnerable to patent expirations.

• Competitive landscape: SGLT2 inhibitors as a class face intense competition, necessitating differentiation through outcome evidence and combination strategies.

• Patent expiry effect: Upcoming patent cliffs for Canagliflozin will challenge revenues but may stimulate market entry by generics enhancing access.

• Future outlook: Innovations in therapy combinations, personalized treatment, and renal/cardiovascular benefits will steer future market trajectories.

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FAQs

1. What factors have contributed to Metformin’s enduring dominance?

   Its proven efficacy, affordability, safety profile, and inclusion as the first-line treatment in guidelines contribute to its sustained market presence, especially in emerging economies.

2. How will patent expiration affect Canagliflozin’s market share?

   Patent expiry will lead to generic versions entering the market, potentially decreasing prices and revenue. This shift necessitates strategic adaptation by original manufacturers, such as developing new indications or formulations.

3. What are the main drivers for Canagliflozin’s growth in the coming years?

   Expanding indications for cardiovascular and renal benefits, increased adoption among clinicians, and growth in emerging markets are primary growth drivers.

4. Are there safety concerns impacting the use of metformin and Canagliflozin?

   Yes. Metformin carries rare risk of lactic acidosis, especially in renal impairment. Canagliflozin has been associated with genital infections and risk of ketoacidosis, prompting regulatory monitoring and label updates.

5. How do regulatory agencies influence the market dynamics of these drugs?

   Agencies’ approval of new indications, safety labeling, and determination of reimbursement policies directly impact prescribing patterns, market access, and revenue potential.

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References

[1] UKNHS. “Metformin.” National Health Service. 2022.

[2] IMS Health. “Global Prescription Market Overview.” 2021.

[3] US FDA. “FDA Approves Canagliflozin for Type 2 Diabetes.” 2013.

[4] McMurray JJ, et al. “Cardiovascular outcomes with canagliflozin in type 2 diabetes.” New England Journal of Medicine, 2017.

[5] International Diabetes Federation. “IDF Diabetes Atlas,” 9th Edition, 2019.

[6] IQVIA. “Global Use of Medicines,” 2021.

[7] EvaluatePharma. “2019 Global Top 10 BioPharma News.” 2020.