Canagliflozin; metformin hydrochloride - Generic Drug Details

What are the generic drug 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 four 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:	4
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

Dosage:

TABLET, EXTENDED RELEASE;ORAL

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	204353-001	Aug 8, 2014		RX	Yes	No			Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016		RX	Yes	No					Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes					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	205879-004	Sep 20, 2016
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014

International Patents for canagliflozin; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	I365186
Taiwan	200510441	Novel compounds
Portugal	2451482

Supplementary Protection Certificates for canagliflozin; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	CR 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119
1651658	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119

Market Dynamics and Financial Trajectory for Canagliflozin plus Metformin Hydrochloride

Last updated: February 14, 2026

Market Overview

The combination of canagliflozin and metformin hydrochloride targets type 2 diabetes mellitus (T2DM), capturing a significant portion of the global anti-diabetic drug market. Market growth is driven by the rising prevalence of T2DM, especially in North America, Europe, and Asia-Pacific, compounded by increasing awareness of combination therapies for better glycemic control.

Market Size and Growth Rate

The global antidiabetic drug market was valued around USD 63 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of approximately 7% through 2027, reaching an estimated USD 90 billion.[1]

Within this, the segment for SGLT2 inhibitors, including canagliflozin, accounts for roughly USD 7 billion in 2021, expanding at roughly 14% CAGR. The market for oral combination therapies with metformin dominates due to the drug’s position as first-line treatment.

Key Drivers

• Increasing T2DM prevalence: The International Diabetes Federation reports over 537 million adults affected globally, expected to reach 643 million by 2030.[2]
• Regulatory approvals: Both canagliflozin and metformin have long-standing approval pathways, allowing for combination formulations.
• Clinical evidence of efficacy: Randomized trials demonstrate improved glycemic control, weight reduction, and cardiovascular benefits with SGLT2-metformin combos, promoting prescriber adoption.
• Patent expiration and generics: Patent expiries have facilitated market entry for generics, expanding accessibility and impacting pricing strategies.

Competitive Landscape

Major players include:

• Janssen Pharmaceuticals (brand: Invokana, for canagliflozin monotherapy; Janssen offers combination options)
• Eli Lilly & Company (FDA approval for Jardiance, an SGLT2 inhibitor)
• Manufacturers of generic formulations: Increasing market share due to patent expirations

Generic combination drugs are estimated to account for approximately 40% of the market volume in 2022, with branded drugs holding a higher price premium.

Pricing and Reimbursement Trends

In the US, the average wholesale price (AWP) of branded canagliflozin-metformin combos ranges between USD 400-600 per month, depending on dosage and formulation. Generic formulations are priced around USD 250-350, enhancing affordability.

Reimbursement policies influence market penetration. Many countries' health systems favor generics, impacting the revenue streams of branded agents.

Financial Trajectory

Revenue estimates for canagliflozin-metformin combination drugs depend heavily on regulatory patents, healthcare policies, and market uptake:

• Peak revenue potential: USD 3-4 billion annually for combination markets by 2025, with US and Europe as primary markets.
• Market share assumptions: Branded drugs could command 60-70% of the market, with generics securing the remainder.
• Pricing dynamics: As patents expire, prices for branded products are expected to decline by 20-30%, while generics gain market share. This shift will influence margins but also expand overall access and volume.
• Impact of biosimilars and new entrants: Innovation in SGLT2 inhibitors and fixed-dose combinations could evolve competitive pressure.

Regulatory and Policy Influence

Continued approval of combination therapies hinges on demonstration of safety and efficacy across diverse populations. Some countries, focusing on cost containment, restrict reimbursement for combination therapies, affecting market growth.

Key Market Challenges

• Patent expiry leading to price erosion
• Competition from emerging SGLT2 inhibitors with superior profiles
• Regulatory barriers and clinical guidelines influencing prescribing habits
• Generics achieving pricing parity, reducing revenue for branded drugs

Projection Summary

Between 2022 and 2027:

Year	Estimated Market Size (USD billion)	CAGR	Key Factors
2022	7	—	Dominance of SGLT2 inhibitors
2023	8.4	14%	Increased adoption of combos
2025	11.2	13.3%	Patent cliff impacts profitability
2027	13.5	8%	Market stabilization, biosimilar entry

Key Takeaways

• The market for canagliflozin-metformin oral combinations is expansive, driven by the global rise in T2DM.
• Patent expiries and generic competition are expected to reduce per-unit revenue but increase volume.
• Branded drugs will maintain a premium in regions with stringent regulation and brand loyalty; generics will dominate volume.
• Innovation in drug formulations and expanding indications can influence future market shares.
• Pricing and reimbursement policies significantly impact financial trajectories, especially in emerging markets.

FAQs

1. How does patent expiration influence the market for canagliflozin-metformin combinations?
Patent expiry typically leads to the entry of generics, reducing prices by 40-60%, decreasing revenue per unit but increasing overall volume.

2. What factors are expected to drive further adoption of canagliflozin and metformin combos?
Clinical evidence of cardiovascular benefits, ease of compliance with fixed-dose combinations, and expanded reimbursement coverage primarily drive adoption.

3. How do emerging markets impact the global market for these drugs?
Emerging markets, with higher T2DM prevalence and cost sensitivity, favor generics and biosimilars, expanding access but reducing profit margins for branded drugs.

4. What regulatory trends could influence the market’s future?
Increased focus on evidence-based prescribing, stricter approval processes for combination therapies, and reimbursement restrictions will shape market growth.

5. What opportunities exist for new entrants in this space?
Developing fixed-dose combinations with improved efficacy, safety profiles, and lower costs offers opportunities to capture market share, especially in generics.

References

[1] MarketWatch, "Diabetes Drugs Market Revenue Analysis," 2022.
[2] International Diabetes Federation, "IDF Diabetes Atlas," 2021.