INVOKAMET Drug Patent Profile

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

Invokamet is a drug marketed by Janssen Pharms and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-one patent family members in forty-eight countries.

The generic ingredient in INVOKAMET 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

Invokamet 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 seventeen 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

International Patents:	271
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	56
Drug Prices:	Drug price information for INVOKAMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVOKAMET
What excipients (inactive ingredients) are in INVOKAMET?	INVOKAMET excipients list
DailyMed Link:	INVOKAMET at DailyMed

See drug prices for INVOKAMET

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

NDA:

204353

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.

Pharmacology for INVOKAMET

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 INVOKAMET

INVOKAMET is protected by five 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	205879-004	Sep 20, 2016		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 XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	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					Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014		RX	Yes	Yes

Expired US Patents for INVOKAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-004	Aug 8, 2014
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-002	Aug 8, 2014

International Patents for INVOKAMET

When does loss-of-exclusivity occur for INVOKAMET?

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Honduras	2009001135
El Salvador	2009003285	FORMA CRISTALINA DEL HEMIHIDRATO DE 1-(BETA-D-GLUCOPIRANOSIL)-4-METIL-3-[ 5-(4-FLUOROFENIL)-2- TIENILMETIL] BENCENO
South Korea	101799944
Malaysia	143203	NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDENT TRANSPORTER
Costa Rica	8402	INDAZOL-O-GLUCOSIDOS SUSTITUTOS
Spain	2527053

Supplementary Protection Certificates for INVOKAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
1651658	122014000050	Germany		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658	637	Finland
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

Market Dynamics and Financial Trajectory for INVOKAMET

Last updated: July 27, 2025

Introduction

INVOKAMET, a combination medication comprising empagliflozin and metformin, was developed by Boehringer Ingelheim in collaboration with Eli Lilly. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), INVOKAMET targets type 2 diabetes mellitus (T2DM), a rapidly expanding global health challenge. This report analyzes the market forces shaping INVOKAMET's trajectory and projects its financial outlook grounded in current trends, competitive landscape, and emerging factors.

Market Overview and Key Drivers

1. Growing Prevalence of Type 2 Diabetes

The global burden of T2DM has surged over the past decade, driven by sedentary lifestyles, obesity, and aging populations. International Diabetes Federation (IDF) estimates highlight over 530 million adults affected worldwide as of 2021, with projections exceeding 700 million by 2045 [1]. This expanding patient base underscores robust demand for effective glucose-lowering therapies.

2. Evolving Treatment Paradigms

Traditional monotherapies—metformin, sulfonylureas, insulin—are increasingly supplemented or replaced by combination therapies that enhance efficacy and reduce adverse effects. SGLT2 inhibitors like empagliflozin (component of INVOKAMET) have gained prominence due to their cardiovascular and renal protective benefits, beyond glycemic control [2].

3. Regulatory and Reimbursement Trends

Regulatory agencies have been supportive of drug innovations that demonstrate improved outcomes, with incentivized approvals for combination therapies. Reimbursement policies favor drugs with proven cost-effectiveness and added clinical value, aiding market penetration.

Competitive Landscape

INVOKAMET faces competition primarily from other fixed-dose combination (FDC) therapies targeting T2DM, including:

• Jardiance (empagliflozin + metformin): Manufactured by Boehringer Ingelheim and Lilly, it mirrors INVOKAMET's formulation.
• Xultophy (insulin degludec/liraglutide): Combining basal insulin and GLP-1 receptor agonist.
• Synjardy (empagliflozin + metformin XR): Also from Boehringer Ingelheim, offering a slightly different dosing profile.

Moreover, emerging agents like dual GIP/GLP-1 receptor agonists (e.g., tirzepatide) threaten to redefine treatment algorithms, potentially impacting INVOKAMET’s future market share.

Pricing and Reimbursement positioning: Competitive pricing strategies, coupled with demonstrated clinical benefits, influence INVOKAMET’s adoption rates, especially in cost-sensitive markets.

Regulatory and Clinical Evidence Influence

The EMPA-REG OUTCOME and EMPA-REG RENAL trials established empagliflozin's cardiovascular and renal benefits, fostering confidence among clinicians and payers [3][4]. Hide significant clinical data underpin INVOKAMET’s value proposition, emphasizing safety and efficacy.

Label Expansion and Indications: The drug has received approval for various indications beyond glucose lowering, including reduced risk of cardiovascular death in T2DM patients with established CVD. These extensions bolster sales potential.

Market Penetration and Adoption

In the U.S., INVOKAMET’s market penetration is improving, driven by increasing physician familiarity with SGLT2 inhibitors’ multi-dimensional benefits. Patient-friendly dosing and favorable safety profiles support adherence, further driving sales growth.

In Europe and Asia, adoption varies, with regulatory pathways, healthcare infrastructure, and economic factors influencing uptake. In emerging markets, affordability and supply chain logistics are critical determinants.

Financial Trajectory and Revenue Outlook

1. Revenue Trends

Initial sales trajectories in North America indicated moderate adoption, aligning with broader market trends favoring innovative combination therapies. Post-approval of additional indications and inclusion in treatment guidelines have spurred revenue acceleration.

2. Growth Catalysts

• Expansion into new markets, notably Asia-Pacific, accelerates topline growth.
• Pipeline advancements, including novel formulations (e.g., extended-release variants), enhance long-term prospects.
• Strategic partnerships with healthcare payers and providers facilitate broader reimbursement coverage.

3. Potential Challenges

• Generic Competition: Patent expirations may prompt biosimilar entries, pressuring margins.
• Pricing pressures amid payers’ cost-containment efforts.
• Emerging competitors with superior efficacy or multi-mechanistic action could diminish market share.

4. Forecasting Revenue

Based on current adoption rates, clinical evidence, and market expansion efforts, analysts project INVOKAMET’s global revenues to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years. This projection considers increased penetration in non-U.S. markets, especially where T2DM prevalence is soaring.

Market Challenges and Opportunities

Challenges

• Pricing and reimbursement hurdles in cost-sensitive markets.
• Clinical competition from newer agents offering additional benefits.
• Regulatory delays impacting rapid expansion.

Opportunities

• Adjunct indications for heart failure and chronic kidney disease.
• Combination with other novel agents, leveraging synergistic effects.
• Digital health integration, supporting adherence and monitoring.

Key Factors Influencing Future Financial Trajectory

• Regulatory approvals for expanded indications will unlock new revenue streams.
• Clinical trial outcomes demonstrating long-term benefits will enhance prescriber confidence.
• Market access strategies tailored to regional healthcare frameworks will determine reach.
• Pricing strategies balancing profitability and affordability will be critical.

Conclusion

INVOKAMET’s market dynamics are shaped by the confluence of increasing T2DM prevalence, evolving treatment protocols, competitive pressures, and regulatory support. Its financial trajectory is poised for sustained growth, contingent upon strategic market expansion, ongoing clinical validation, and navigating pricing landscapes.

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Key Takeaways

• The escalating global diabetes burden offers a substantial, expanding market for INVOKAMET.
• Clinical evidence of cardiovascular and renal benefits enhances its attractiveness to prescribers and payers.
• Competition from similar FDCs and emerging novel therapies necessitates strategic positioning.
• Market expansion into Asia-Pacific and other emerging regions will significantly influence revenue growth.
• Future success hinges on regulatory approvals for new indications, innovative formulations, and durable competitive advantages.

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FAQs

1. How does INVOKAMET differentiate itself from other SGLT2 inhibitors?
INVOKAMET combines empagliflozin with metformin in a fixed-dose formulation, offering convenience and established cardiovascular benefits. Its clinical trials demonstrate additional renal protection, setting it apart from some competitors.

2. What are the primary markets driving INVOKAMET’s growth?
The United States remains the primary driver due to established awareness and reimbursement infrastructure, with rapid growth anticipated in Europe and Asia-Pacific markets through expanded access and increasing T2DM prevalence.

3. What are the implications of upcoming biosimilar entries for INVOKAMET?
Patent expirations could introduce biosimilars and generics, potentially reducing prices and profit margins. Strategic differentiation through clinical benefits and extended indications will be vital to maintaining market share.

4. How might emerging therapies impact INVOKAMET’s future market position?
Innovative agents like dual GIP/GLP-1 receptor agonists, with superior efficacy and weight loss benefits, could challenge INVOKAMET’s dominance, requiring continuous innovation and marketing strategies.

5. What role do regulatory approvals play in INVOKAMET’s financial outlook?
Regulatory clearances for new indications, such as heart failure and chronic kidney disease, open new markets and patient segments, boosting sales and reinforcing long-term growth prospects.

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Sources
[1] IDF Diabetes Atlas, 9th Edition. International Diabetes Federation. 2021.
[2] Zinman B, et al. "Empagliflozin, cardiovascular outcomes, and mortality in Type 2 diabetes." NEJM, 2015.
[3] McMurray JJ, et al. "Effects of empagliflozin on cardiovascular outcomes in type 2 diabetes." NEJM, 2018.
[4] Wanner C, et al. "Empagliflozin and renal outcomes in type 2 diabetes." NEJM, 2020.