INVOKANA Drug Patent Profile

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

Invokana 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 INVOKANA is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Invokana

Invokana 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.

There are five tentative approvals for the generic drug (canagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INVOKANA

International Patents:	220
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	23
Patent Applications:	512
Drug Prices:	Drug price information for INVOKANA
Drug Sales Revenues:	Drug sales revenues for INVOKANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVOKANA
What excipients (inactive ingredients) are in INVOKANA?	INVOKANA excipients list
DailyMed Link:	INVOKANA at DailyMed

See drug prices for INVOKANA

See drug sales revenues for INVOKANA

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

Constraining patent/regulatory exclusivity:

7,943,582*PED

NDA:

204042

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 INVOKANA

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 2
University of Colorado, Denver	Phase 2
Boston Medical Center	Phase 2

See all INVOKANA clinical trials

Pharmacology for INVOKANA

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

Paragraph IV (Patent) Challenges for INVOKANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVOKANA	Tablets	canagliflozin	100 mg and 300 mg	204042	10	2017-03-29

US Patents and Regulatory Information for INVOKANA

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

This potential generic entry date is based on patent 7,943,582.

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	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No	7,943,582*PED				Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes	7,943,582*PED				Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No	8,513,202*PED				Y

EU/EMA Drug Approvals for INVOKANA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Invokana	canagliflozin	EMEA/H/C/002649 Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2013-11-15

International Patents for INVOKANA

When does loss-of-exclusivity occur for INVOKANA?

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 INVOKANA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I599360
Norway	344354
Malaysia	147375	INDOLE DERIVATIVES

Supplementary Protection Certificates for INVOKANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	1490027-8	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118
1651658	C20140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118

Market Dynamics and Financial Trajectory for the Drug: Invokana

Introduction

Invokana, developed by Johnson & Johnson, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used primarily for the treatment of type 2 diabetes. Despite its initial success, the drug has faced significant challenges in recent years, impacting its market share and financial performance.

Market Share and Competitive Landscape

Invokana has been losing ground to its major competitor, Jardiance, developed by Eli Lilly and Boehringer Ingelheim. As of July 2017, Invokana's market share had dropped to 45% from 51% in December of the previous year, while Jardiance's share increased to 23% from 16% during the same period[1].

Factors Contributing to Decline

Several factors have contributed to Invokana's decline in market share:

Increased Contracting Discounts and Medicaid Utilization

Higher contracting discounts and increased utilization in Medicaid programs have reduced the drug's revenue. These discounts and the shift in patient demographics have negatively impacted Invokana's financial performance[1].

Regulatory Warnings

In May 2017, the U.S. FDA mandated that Johnson & Johnson add warnings to Invokana's label about an increased risk of leg and foot amputations. This labeling change, combined with the results of the Canvas cardiovascular outcomes trial, which confirmed a twofold increase in amputation rates, has further eroded confidence in the drug[1].

Competitive Outcomes Data

While Invokana demonstrated some cardiovascular benefits, its outcomes data did not match the robust results seen with Jardiance. Jardiance showed a 38% reduction in death risk, significantly outperforming Invokana's 13% reduction, which has been a critical factor in Jardiance's market dominance[1].

Financial Performance

The financial trajectory of Invokana reflects its declining market share and the challenges it faces:

Revenue Shortfalls

In the second quarter of 2017, Invokana's sales were $76 million below consensus estimates, coming in at $295 million instead of the expected $371 million. This shortfall was significant, especially given the overall market expansion of 3.5% during the same period[1].

Quarterly and Annual Sales

The drug's sales have continued to struggle. For instance, in the first quarter of 2023, Invokana's sales were included in the "Other" category of Johnson & Johnson's financial report, indicating a lack of standalone growth or significance compared to other products[5].

Impact of Regulatory and Market Changes

Regulatory changes and market dynamics have further complicated Invokana's position:

FDA Approvals and Label Changes

The FDA's requirement to add amputation risk warnings to Invokana's label has had a lasting impact on its market perception. This, combined with the approval of competitors like Jardiance and Farxiga for additional indications such as heart failure and chronic kidney disease, has shifted market preferences[4].

Government Initiatives

Government initiatives, such as the inclusion of Jardiance in the “Drug Price Negotiation Program” under the Inflation Reduction Act, have also influenced market dynamics, making it harder for Invokana to regain its lost ground[4].

Future Outlook

Given the current trends, the future outlook for Invokana appears challenging:

Market Growth of SGLT2 Inhibitors

The global SGLT2 inhibitors market is projected to grow at a CAGR of 7.71% from 2024 to 2030, driven by increasing incidence of type 2 diabetes and cardiovascular diseases. However, Invokana is not expected to be a major beneficiary of this growth due to its declining market share and competitive disadvantages[4].

Competitive Dominance

Jardiance and Farxiga are expected to continue dominating the market, with Jardiance accounting for 52.60% of the global revenue in 2023 and anticipated to grow significantly over the forecast period. Farxiga's recent approvals for new indications will also contribute to its market share[4].

Key Takeaways

• Invokana has lost significant market share to competitors like Jardiance and Farxiga.
• Regulatory warnings and adverse outcomes data have negatively impacted Invokana's sales.
• The drug's financial performance has been below expectations, reflecting its declining market position.
• The SGLT2 inhibitors market is growing, but Invokana is unlikely to regain its former market share.

FAQs

Q: What are the main reasons for Invokana's decline in market share?

A: The main reasons include increased contracting discounts, higher Medicaid utilization, regulatory warnings about amputation risks, and competitive outcomes data favoring rivals like Jardiance.

Q: How has the FDA's labeling change affected Invokana?

A: The FDA's requirement to add warnings about an increased risk of leg and foot amputations has significantly impacted Invokana's market perception and sales.

Q: What is the current market size and growth projection for SGLT2 inhibitors?

A: The global SGLT2 inhibitors market was estimated at $15.85 billion in 2023 and is projected to grow at a CAGR of 7.71% from 2024 to 2030[4].

Q: Which drug dominates the SGLT2 inhibitors market?

A: Jardiance, developed by Eli Lilly and Boehringer Ingelheim, dominates the market, accounting for 52.60% of the global revenue in 2023[4].

Q: What are the additional indications approved for Jardiance and Farxiga?

A: Jardiance and Farxiga have been approved for indications beyond type 2 diabetes, including heart failure and chronic kidney disease. Farxiga was recently approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure[4].

Sources

1. FiercePharma: J&J's Invokana continues downward market-share spiral as Lilly, BI's Jardiance advances
2. Mitsubishi Gas Chemical: Operational Summary for the First Quarter of Fiscal Year Ending
3. DrugBank Blog: Investment Trends in Pharmaceutical Research
4. Grand View Research: SGLT2 Inhibitors Market Size, Share & Growth Report, 2030
5. Johnson & Johnson: 2023 First-Quarter reported sales growth of 5.6% to $24.7 Billion