INVOKAMET XR Drug Patent Profile

Which patents cover Invokamet Xr, and when can generic versions of Invokamet Xr launch?

Invokamet Xr is a drug marketed by Janssen Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty patent family members in forty-five countries.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Invokamet Xr

Invokamet Xr was eligible for patent challenges on March 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

There have been twenty-five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INVOKAMET XR

International Patents:	220
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for INVOKAMET XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVOKAMET XR
DailyMed Link:	INVOKAMET XR at DailyMed

See drug prices for INVOKAMET XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INVOKAMET XR

NDA:

205879

Dosage:

TABLET, EXTENDED RELEASE;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.

Pharmacology for INVOKAMET XR

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

Paragraph IV (Patent) Challenges for INVOKAMET XR

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

US Patents and Regulatory Information for INVOKAMET XR

INVOKAMET XR is protected by four US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for INVOKAMET XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016
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	205879-003	Sep 20, 2016

International Patents for INVOKAMET XR

When does loss-of-exclusivity occur for INVOKAMET XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Guatemala

Honduras

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INVOKAMET XR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2896397	Nouveaux composés présentant une activité inhibitrice contre le transporteur de glucose dépendant du sodium (Novel compounds having inhibitory activity against sodium-dependant glucose transporter)
Canada	2549017	INDAZOLES-O-GLUCOSIDES SUBSTITUES (SUBSTITUTED INDAZOLE-O-GLUCOSIDES)
Taiwan	200510441	Novel compounds
Croatia	P20130124

Supplementary Protection Certificates for INVOKAMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	C 2014 017	Romania		PRODUCT NAME: CANAGLIFLOZIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/884; DATE OF NATIONAL AUTHORISATION: 20131115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/884; DATE OF FIRST AUTHORISATION IN EEA: 20131115
1651658	164 1-2014	Slovakia		PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658	300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	C20140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013

Market Dynamics and Financial Trajectory for INVOKAMET XR

Last updated: July 28, 2025

Introduction

INVOKAMET XR, a fixed-dose combination drug comprising empagliflozin and metformin extended-release, has gained prominence within the global diabetes management market. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it targets type 2 diabetes mellitus (T2DM), a condition affecting over 400 million individuals worldwide. The evolving landscape of diabetes therapeutics, driven by rising prevalence, healthcare reimbursement trends, and innovation, shapes the market trajectory for INVOKAMET XR.

This analysis delineates the key factors influencing the market dynamics of INVOKAMET XR and projects its financial outlook, emphasizing competitive positioning, regulatory developments, payer strategies, and demographic trends.

Market Overview

Type 2 diabetes remains a pressing global health challenge, with the World Health Organization (WHO) estimating that the number of affected individuals will approach 700 million by 2045 [1]. The treatment paradigm encompasses lifestyle modification, oral hypoglycemics, and insulins. Among oral agents, SGLT2 inhibitors like empagliflozin have revolutionized management by providing additional benefits such as cardiovascular and renal protection, apart from glycemic control.

INVOKAMET XR combines empagliflozin with metformin extended-release, streamlining therapy for patients inadequately controlled on monotherapy. This formulation offers convenience, improved adherence, and potential therapeutic benefits, positioning it favorably in the market.

Key Market Drivers

1. Rising Global Diabetes Prevalence

The relentless increase in T2DM prevalence propels demand for combination therapies, notably those with proven cardiovascular and renal benefits. Governments and healthcare systems prioritize therapies that offer comprehensive risk reduction, bolstering INVOKAMET XR's growth prospects.

2. Clinical Evidence and Label Expansion

Clinical trials such as EMPA-REG OUTCOME have demonstrated empagliflozin’s cardiovascular benefits, leading to label expansions and heightened physician confidence [2]. As more evidence accrues, healthcare providers are increasingly prescribing SGLT2 inhibitor-based combination therapies, including INVOKAMET XR.

3. Favorable Pharmacological Profile

The fixed-dose combination reduces pill burden and improves compliance. Extended-release metformin minimizes gastrointestinal side effects compared to immediate-release formulations. These attributes enhance patient adherence and therapeutic outcomes, positively impacting sales.

4. Regulatory and Reimbursement Trends

Regulatory approvals in major markets like the U.S., Europe, and Japan bolster INVOKAMET XR’s availability. Payer coverage, especially with formulary inclusion in payer plans emphasizing cardiovascular protection, further supports market penetration.

Market Challenges and Limitations

1. Patent Expiry and Generic Competition

Patent expiration schedule for key components could introduce generics, exerting downward pressure on prices and margins. The original patent for INVOKAMET XR was filed around 2017, with competitive generics expected by the late 2020s [3].

2. Market Saturation and Competitive Innovations

Numerous combination drugs, including other SGLT2 inhibitors and metformin formulations, compete for market share. Additionally, emerging therapies such as dual GPP4 and GLP-1 receptor agonist combinations expand treatment options, challenging INVOKAMET XR’s dominance.

3. Safety Concerns

Potential adverse effects, including genital infections and rare cases of diabetic ketoacidosis, necessitate cautious prescribing. Any new safety signals could impact market acceptance.

4. Pricing and Reimbursement Hurdles

In some regions, stringent cost-effectiveness evaluations and formulary restrictions limit adoption. The high cost of SGLT2 inhibitors influences prescribing behaviors, especially in value-sensitive healthcare systems.

Financial Trajectory and Revenue Outlook

Historical Sales Performance

Since its launch, INVOKAMET XR has experienced steady sales growth. According to IQVIA data, in 2022, the drug generated approximately $700 million globally, with the U.S. accounting for a significant market share [4]. The growth trajectory reflects increasing adoption driven by cardiovascular benefits and the rising T2DM burden.

Future Growth Projections

Projections suggest a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, propelled by:

• Expansion into emerging markets, where diabetes prevalence is escalating rapidly.
• Broadened label indications, including chronic kidney disease.
• Incremental uptake as guidelines increasingly recommend SGLT2 inhibitors for comprehensive cardiometabolic risk management.

Market Expansion Strategies

Pharmaceutical companies are investing in:

• Product Differentiation: Emphasizing cardiovascular and renal benefits.
• Patient Support Programs: Enhancing adherence.
• Pricing Strategies: Navigating payer negotiations to maintain competitiveness.
• Pipeline Development: Combining INVOKAMET XR with other agents, such as GLP-1 receptor agonists, to create next-generation therapies.

Risks to Financial Growth

Factors such as patent challenges, emerging generic competition, regulatory setbacks, or adverse safety reports could temper revenue growth. The potential for biosimilars and alternative therapies to erode market share remains a concern.

Regulatory and Market Expansion Outlook

Regulatory Landscape

The ongoing approvals and label extensions across major markets support sustained revenue streams. Notably, the U.S. FDA and EMA approvals for indications like renal benefits and cardiovascular risk reduction bolster clinical utility claims.

Market Penetration

As awareness increases among clinicians and patients, especially within comprehensive diabetes management strategies, INVOKAMET XR’s utilization is expected to rise. Targeted markets include North America, Europe, Japan, and emerging economies like China and India.

Potential for License Extensions

Future approvals for wider indications (e.g., heart failure, chronic kidney disease) could diversify revenue sources. Additionally, formulation innovations (e.g., once-weekly versions) might further enhance adherence and sales.

Concluding Insights

INVOKAMET XR’s market trajectory reflects a confluence of demographic trends, clinical advancements, and strategic positioning. Its role as a cardiovascular and renal protective agent within the T2DM therapeutic landscape positions it favorably for sustained growth, albeit within competitive and patent-sensitive boundaries. Navigating evolving regulations, competitive pressures, and pricing challenges will be crucial for maximizing its financial potential.

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Key Takeaways

• Growing Market Demand: The increasing prevalence of type 2 diabetes and shifting treatment guidelines favor combination therapies like INVOKAMET XR.
• Clinical Evidence Leverage: Demonstrated cardiovascular and renal benefits underpin its rising adoption.
• Competitive Landscape: Patent expirations and emerging therapies demand strategic innovation and differentiations.
• Revenue Outlook: Projected CAGR of 8-10% over five years, driven by international expansion and label extensions.
• Strategic Risks: Patent challenges, safety concerns, and reimbursement hurdles could temper growth.

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FAQs

1. How does INVOKAMET XR compare to other diabetes combination therapies?
INVOKAMET XR distinguishes itself with proven cardiovascular and renal benefits, supported by extensive clinical trials. Its fixed-dose formulation enhances adherence compared to free-drug regimens, although its market shares face competition from other SGLT2 inhibitors and combination products.

2. What are the primary safety concerns associated with INVOKAMET XR?
Potential adverse effects include urinary and genital infections, dehydration, and, rarely, diabetic ketoacidosis. These risks necessitate appropriate patient selection and monitoring, which could influence prescribing.

3. How do patent expirations impact INVOKAMET XR’s market prospects?
Patent expirations threaten exclusivity, paving the way for generic competitors that can erode market share and reduce profit margins. Managing lifecycle strategies and developing next-generation formulations become vital.

4. In which regions is INVOKAMET XR expected to see the fastest growth?
Emerging markets like China and India, driven by rising diabetes prevalence and expanding healthcare infrastructure, are poised for rapid growth. Developed markets are expected to maintain stable inflows due to clinical guideline endorsements.

5. What future opportunities exist to expand INVOKAMET XR’s indications?
Label extensions for conditions such as heart failure and chronic kidney disease, alongside formulations with improved dosing convenience, offer avenues for growth and increased market penetration.

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References:

[1] WHO. (2019). Diabetes Fact Sheet. WHO.
[2] Zinman, B., et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 373(22), 2117-2128.
[3] Pharmaceutical patent databases and regulatory filings.
[4] IQVIA. (2022). Global Diabetes Care Market Data.