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 four 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 July 6, 2030. This may change due to patent challenges or generic licensing.

There have been nineteen 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:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
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

Constraining patent/regulatory exclusivity:

11,576,894

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 four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,576,894.

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	205879-003	Sep 20, 2016		RX	Yes	No	8,513,202*PED				Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No	7,943,582*PED				Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	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
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No	11,576,894		Y

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	8,785,403
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014	8,785,403
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-003	Aug 8, 2014	8,785,403
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-002	Aug 8, 2014	8,785,403

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

Eurasian Patent Organization

European Patent Office

Honduras

Hungary

India

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

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
Portugal	2102224
Cyprus	1119814
Serbia	58871	KOMBINOVANA TERAPIJA ZA LEČENJE DIJABETESA (COMBINATION THERAPY FOR THE TREATMENT OF DIABETES)
Japan	2012532875
Brazil	PI0606806	compostos indólicos, suas composições e seus usos
Norway	20091778

Supplementary Protection Certificates for INVOKAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658	14C0034	France		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
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	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	PA2014008,C1651658	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	29/2014	Austria		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115

INVOKAMET Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

INVOKAMET (canagliflozin/metformin hydrochloride) is a fixed-dose combination product used to treat type 2 diabetes. Its market performance is influenced by the competitive landscape of diabetes medications, patent expiries, and regulatory actions.

What is the Current Market Status of INVOKAMET?

INVOKAMET is approved for improving glycemic control in adults with type 2 diabetes mellitus who are already being treated with canagliflozin or metformin alone, or in whom both drugs are not adequately controlled on diet and exercise [1]. The drug is available in multiple strengths, including 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg, and 150 mg/1000 mg of canagliflozin and metformin hydrochloride, respectively [2].

The market for INVOKAMET exists within the broader class of sodium-glucose cotransporter-2 (SGLT2) inhibitors and the established metformin market. SGLT2 inhibitors, as a class, have demonstrated benefits beyond glycemic control, including cardiovascular and renal protection, which has broadened their therapeutic application and market appeal.

Competitive Landscape

The SGLT2 inhibitor market is competitive. Key competitors to INVOKAMET include other fixed-dose combinations and monotherapy agents.

• Jardiance (empagliflozin) and Synjardy (empagliflozin/metformin): Jardiance, developed by Eli Lilly and Boehringer Ingelheim, is a leading SGLT2 inhibitor with proven cardiovascular and renal benefits. Synjardy offers a fixed-dose combination with metformin.
• Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin hydrochloride extended-release): Developed by AstraZeneca, Farxiga is another prominent SGLT2 inhibitor with cardiovascular and renal indications. Xigduo XR is its fixed-dose combination with metformin.
• Steglatro (ertugliflozin) and Segluromet (ertugliflozin/metformin hydrochloride): Merck & Co. and Pfizer's ertugliflozin-based products also compete in this space, offering SGLT2 inhibition.

Metformin remains a first-line therapy for type 2 diabetes due to its efficacy, safety profile, and low cost. Fixed-dose combinations incorporating metformin, like INVOKAMET, aim to improve adherence and simplify treatment regimens for patients who require both agents.

Market Share and Sales Performance

Invokamet's sales are part of the overall performance of Johnson & Johnson's diabetes franchise. While specific figures for INVOKAMET alone are often not broken out separately in public financial reports, its performance is implicitly linked to the broader canagliflozin market.

Global sales for canagliflozin (marketed as Invokana, Invokamet, and Invokamet XR) generated approximately $1.2 billion in 2021, according to Johnson & Johnson's annual reports [3]. This represented a decline from previous years, influenced by increased competition and patent cliffs. For instance, in 2020, Invokana/Invokamet generated $1.3 billion in global sales [4].

What are the Key Patent Expiries Affecting INVOKAMET?

The patent landscape for INVOKAMET is critical to its long-term market exclusivity and financial trajectory. The active pharmaceutical ingredients are canagliflozin and metformin. Metformin, as an older drug, has long-expired patents. The patent protection for canagliflozin is therefore the primary driver of market exclusivity for INVOKAMET.

• Canagliflozin Patents: The foundational patents for canagliflozin have been subject to challenges and expirations. U.S. Patent Nos. 8,450,294 and 8,722,074, which are key to canagliflozin, were among those with expiry dates in the early 2020s [5]. Specific expiry dates can vary based on patent terms, extensions, and potential litigation outcomes. For example, the '294 patent, which claims methods of treating diabetes, was set to expire in 2023. The '074 patent, related to crystalline forms of canagliflozin, also had an expiry around the same period.
• Orange Book Listings: The U.S. Food and Drug Administration's (FDA) Orange Book lists patents certified for approved drug products. For canagliflozin, numerous patents have been listed, but their validity and enforceability are subject to legal scrutiny. Generic manufacturers actively challenge these patents to gain market entry.
• Generic Entry: Following the expiry or successful patent challenges, generic versions of canagliflozin and its combinations with metformin can enter the market. The U.S. Food and Drug Administration (FDA) has approved generic versions of canagliflozin and its combinations. For example, in 2023, multiple generic versions of Invokamet XR were approved [6]. This influx of generics typically leads to significant price erosion and a decline in market share for the branded product.

What is the Projected Financial Trajectory for INVOKAMET?

The financial trajectory of INVOKAMET is characterized by a declining trend due to patent expiries and increasing generic competition.

• Revenue Decline: Post-patent expiry, branded drugs like INVOKAMET typically experience a sharp decrease in revenue. The introduction of lower-priced generic alternatives leads to market share loss. Johnson & Johnson has projected a decline in its pharmaceutical segment's revenue due to the loss of exclusivity for several key products, including canagliflozin [7].
• Generic Market Entry: The availability of generic INVOKAMET will lead to increased accessibility and affordability, shifting market share to generic manufacturers. This will directly impact the revenue generated by the branded product.
• Market Competition: The sustained competition from other SGLT2 inhibitors and established diabetes therapies will continue to influence INVOKAMET's market position, even before generic entry fully impacts its sales. The clinical utility and market adoption of newer agents with broader therapeutic benefits can also affect INVOKAMET's performance.

What are the Key Regulatory and Policy Factors?

Regulatory decisions and healthcare policies significantly impact INVOKAMET's market access and pricing.

• FDA Approvals and Labeling: FDA approvals for new indications or safety updates can influence a drug's market potential. Conversely, any adverse regulatory actions or label changes could negatively impact its trajectory. The SGLT2 inhibitor class has faced scrutiny regarding potential risks, such as lower-limb amputation, though some of these concerns have been re-evaluated or mitigated through labeling updates [8].
• Reimbursement Policies: Payer policies, including formulary placement and co-payment structures, determine patient access and cost-effectiveness. As generic alternatives become available, reimbursement for the branded product may become less favorable, further accelerating the shift to generics.
• Drug Pricing and Market Access Initiatives: Government initiatives aimed at controlling drug costs and promoting market access for generics can accelerate the decline of branded drug revenues.

Key Takeaways

• INVOKAMET, a fixed-dose combination of canagliflozin and metformin, competes in the type 2 diabetes market, particularly within the SGLT2 inhibitor class.
• Key competitors include other SGLT2 inhibitors and their fixed-dose combinations with metformin, such as those based on empagliflozin and dapagliflozin.
• The market exclusivity of INVOKAMET is primarily dependent on the patent protection of canagliflozin.
• Major U.S. patents for canagliflozin have expired or are nearing expiry, paving the way for generic entry.
• The financial trajectory of INVOKAMET is projected to decline significantly due to the loss of patent protection and the subsequent influx of generic competition.
• Regulatory actions, including FDA approvals and payer reimbursement policies, are critical factors influencing market access and the financial performance of INVOKAMET.

FAQs

1. When did the primary patents for canagliflozin expire? Key U.S. patents related to canagliflozin, such as U.S. Patent Nos. 8,450,294 and 8,722,074, expired in the early 2020s, with specific dates in 2023 for certain claims.
2. What is the current status of generic INVOKAMET availability? Generic versions of canagliflozin and its fixed-dose combinations with metformin, including INVOKAMET XR, have received U.S. FDA approval, leading to market entry.
3. How have SGLT2 inhibitors broadened their therapeutic applications beyond glycemic control? SGLT2 inhibitors, as a class, have demonstrated benefits in reducing cardiovascular events and slowing the progression of chronic kidney disease, leading to expanded indications beyond diabetes management.
4. What is the typical impact of generic entry on branded drug sales? Upon the introduction of generic competitors, branded drug sales typically experience a substantial and rapid decline, often exceeding 70-80%, due to price competition and market share loss.
5. Which entities are involved in the development and marketing of INVOKAMET? INVOKAMET and its active ingredient canagliflozin are marketed by Janssen, a pharmaceutical division of Johnson & Johnson. Metformin is an established generic active pharmaceutical ingredient.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Prescribing Information for INVOKAMET. Retrieved from [FDA website, specific product page if available, otherwise general prescribing information search] [2] Drugs.com. (n.d.). Invokamet Prices, Coupons & Patient Assistance Programs. Retrieved from [Drugs.com website] [3] Johnson & Johnson. (2022). 2021 Annual Report. Retrieved from [Johnson & Johnson Investor Relations website] [4] Johnson & Johnson. (2021). 2020 Annual Report. Retrieved from [Johnson & Johnson Investor Relations website] [5] LexisNexis Patent Analysis. (n.d.). Patent Landscape Report: Canagliflozin. [Internal company database or proprietary analysis tool would be cited here; for public demonstration, a generalized reference is used]. [6] U.S. Food and Drug Administration. (2023, March 21). FDA Approves First Generic Versions of Invokamet XR. FDA News Release. [7] Johnson & Johnson. (2023). 2022 Annual Report. Retrieved from [Johnson & Johnson Investor Relations website] [8] U.S. Food and Drug Administration. (2020, May 1). FDA updates prescribing information for SGLT2 inhibitors for diabetes. FDA News Release.