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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-nine patent family members in forty-seven 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 February 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:	269
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2
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 twelve US patents.

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	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No			Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016		RX	Yes	No			Y	Y
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	204353-003	Aug 8, 2014		RX	Yes	No			Y	Y
Janssen Pharms	INVOKAMET	canagliflozin; metformin hydrochloride	TABLET;ORAL	204353-001	Aug 8, 2014		RX	Yes	No			Y	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
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	FORMA CRISTALINAS DEL HEMIHIDRATO DE 1-(B-D-GLUCOPIRANOSIL)- 4-METIL,3-{5-(4-FLUOROFENIL)-2-TIENILMETIL} BENCENO
Mexico	2009005857	FORMA CRISTALINA DEL HEMIHIDRATO DE 1-(BETA-D-GLUCOPIRANOSIL)-4-ME TIL-3[5-(4-FLUOROFENIL)-2-TIENILMETIL]BENCENO. (CRYSTALLINE FORM OF 1- (β-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL] BENZENE HEMIHYDRATE.)
World Intellectual Property Organization (WIPO)	2005012243
Eurasian Patent Organization	010655	ЗАМЕЩЕННЫЕ ИНДАЗОЛ-О-ГЛЮКОЗИДЫ (SUBSTITUTED INDAZOLE-O-GLUCOSIDES)
Brazil	PI0413233	novos compostos
Serbia	20060323	SUPSTITUISANI INDOL-O-GLUKOZIDI (SUBSTITUTED INDOLE-O-GLUCOSIDES)

Supplementary Protection Certificates for INVOKAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	C20140011 00102	Estonia		PRODUCT NAME: KANAGLIFLOSIIN;REG NO/DATE: K(2013)8171 (LOPLIK) 15.11.2013
1651658	29/2014	Austria		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884 20131115
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	2014C/027	Belgium		PRODUCT NAME: CANAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/13/884 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	CA 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115

INVOKAMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVOKAMET

Introduction

INVOKAMET, a combination of canagliflozin (Invokana) and metformin, is a medication used to treat type 2 diabetes. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare professionals.

Market Share and Competition

INVOKAMET operates in a competitive landscape dominated by SGLT2 inhibitors. As of 2017, Invokana, the primary component of INVOKAMET, held a significant market share but was losing ground to its main competitor, Jardiance (empagliflozin), developed by Eli Lilly and Boehringer Ingelheim. Invokana's market share dropped from 51% to 45% between December and July of that year, while Jardiance's share increased from 16% to 23% during the same period[1].

Sales Performance

The sales performance of INVOKAMET has been impacted by several factors, including increased contracting discounts and higher utilization in Medicaid programs. In the second quarter of 2017, Invokana's sales were $76 million below consensus estimates, reflecting a 20.5% shortfall. This decline was part of a broader trend where Invokana's sales were affected by market share losses and other economic factors[1].

Financial Impact

The financial performance of INVOKAMET is closely tied to the overall performance of its parent drug, Invokana. The decline in Invokana's sales has had a significant impact on Johnson & Johnson's financials. For instance, the reduced market share and increased discounts led to lower revenue and profitability for the drug[1].

Market Trends and Growth

The diabetes treatment market is evolving, with new drugs and therapies emerging. The GLP-1 market, for example, is expanding rapidly due to the efficacy of these drugs in treating obesity and other conditions. While INVOKAMET is not a GLP-1 drug, the overall growth in the diabetes treatment market can influence its sales. However, INVOKAMET faces stiff competition from newer and more versatile treatments[3].

Pricing and Cost Factors

Pricing is a critical factor in the pharmaceutical market. INVOKAMET's pricing strategy has been affected by increased competition and the need to offer discounts to maintain market share. The higher utilization in Medicaid programs, which often negotiate lower prices, has also impacted the drug's revenue. As the market becomes more competitive, the pricing pressure on INVOKAMET is likely to continue[1].

Regulatory and Safety Concerns

Regulatory and safety concerns can significantly impact the financial trajectory of a drug. For Invokana, new warnings and safety concerns have been a challenge. For example, warnings related to amputations and other adverse effects have affected its market perception and sales. These concerns can lead to increased regulatory scrutiny and potential legal liabilities, further impacting the drug's financial performance[1].

Patient Population and Demand

The demand for INVOKAMET is influenced by the size and needs of the patient population. The diabetes market is large and growing, but the specific demand for SGLT2 inhibitors like INVOKAMET can be affected by the availability of alternative treatments. As new drugs with broader therapeutic benefits, such as GLP-1s, enter the market, the demand for INVOKAMET may be impacted[3].

Future Outlook

The future outlook for INVOKAMET is complex and influenced by multiple factors. The drug's ability to maintain market share will depend on its pricing strategy, the introduction of new competitors, and any changes in regulatory or safety profiles. Additionally, the overall trend towards more effective and versatile diabetes treatments could further challenge INVOKAMET's market position.

Impact of New Therapies

New therapies, particularly GLP-1 drugs, are expected to significantly expand the diabetes treatment market. These drugs, such as semaglutide (Wegovy), have shown promising results in reducing major cardiovascular events and treating other serious health conditions. The potential introduction of oral GLP-1s could further disrupt the market, offering patients more affordable and convenient treatment options[3].

Cost Structure and Manufacturing

The cost structure and manufacturing efficiency of INVOKAMET will be crucial in maintaining its competitiveness. As the market becomes more competitive, the ability to reduce costs without compromising quality will be essential. This could involve optimizing manufacturing processes and negotiating better deals with suppliers.

Global Market Potential

The global market potential for diabetes treatments is vast, with estimates suggesting a total addressable market of around $100 billion for GLP-1 drugs alone. While INVOKAMET operates in a different segment, the overall growth in the diabetes market presents opportunities for all treatments. However, INVOKAMET must navigate the competitive landscape to capitalize on these opportunities[3].

Key Takeaways

• Market Share: INVOKAMET faces significant competition, particularly from Jardiance, leading to a decline in market share.
• Sales Performance: The drug's sales have been impacted by increased discounts and higher Medicaid utilization.
• Financial Impact: The decline in sales has affected Johnson & Johnson's financials, highlighting the need for strategic adjustments.
• Market Trends: The emergence of new therapies, such as GLP-1 drugs, is reshaping the diabetes treatment market.
• Pricing and Cost Factors: Pricing pressure and cost management are critical for maintaining competitiveness.
• Regulatory and Safety Concerns: Safety warnings and regulatory issues can significantly impact the drug's market position.
• Future Outlook: The future of INVOKAMET depends on its ability to adapt to market changes, including the introduction of new therapies and changes in patient demand.

FAQs

What is the current market share of INVOKAMET compared to its competitors?

As of 2017, Invokana, the primary component of INVOKAMET, held a market share of 45%, down from 51% in December of the same year, while Jardiance held 23%, up from 16%[1].

How have sales of INVOKAMET been affected by market dynamics?

Sales of INVOKAMET have been impacted by increased contracting discounts, higher utilization in Medicaid programs, and loss of market share to competitors like Jardiance[1].

What are the key factors influencing the financial trajectory of INVOKAMET?

Key factors include market share losses, pricing pressure, regulatory and safety concerns, and the emergence of new and more versatile diabetes treatments[1][3].

How does the introduction of new therapies like GLP-1 drugs affect INVOKAMET?

The introduction of GLP-1 drugs, which offer broader therapeutic benefits and potentially lower costs, could further challenge INVOKAMET's market position and demand[3].

What is the estimated global market potential for diabetes treatments?

The estimated global market potential for diabetes treatments, particularly for GLP-1 drugs, is around $100 billion, indicating a large and growing market[3].

Sources

1. FiercePharma: J&J's Invokana continues downward market-share spiral as Lilly, BI's Jardiance advances[1].
2. Mitsubishi Gas Chemical: Operational Summary for the First Quarter of Fiscal Year Ending[2].
3. Goldman Sachs: Weighing the GLP-1 market[3].
4. GlobalData: Net Present Value Model: Invokana/Invokamet[4].
5. PharmaCompass: INVOKAMET | Annual Sales Report[5].