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INVOKAMET XR Drug Patent Profile

When do Invokamet Xr patents expire, and what generic alternatives are available?

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

This drug has two hundred and nineteen 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 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 XR

International Patents:	219
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2
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

Constraining patent/regulatory exclusivity:

7,943,582

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 eleven US patents.

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	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	7,943,788		Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	8,785,403		Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016		RX	Yes	No	8,513,202		Y	Y
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-004	Sep 20, 2016		RX	Yes	Yes	7,943,582		Y	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	205879-004	Sep 20, 2016	8,785,403
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-003	Sep 20, 2016	8,785,403
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-002	Sep 20, 2016	8,785,403
Janssen Pharms	INVOKAMET XR	canagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205879-001	Sep 20, 2016	6,723,340

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
Australia	2004260760	Novel compounds
Spain	2531660
Eurasian Patent Organization	200601552	ЗАМЕЩЕННЫЕ КОНДЕНСИРОВАННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ С-ГЛИКОЗИДЫ
Canada	2549017	INDAZOLES-O-GLUCOSIDES SUBSTITUES (SUBSTITUTED INDAZOLE-O-GLUCOSIDES)

Supplementary Protection Certificates for INVOKAMET XR

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

INVOKAMET XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INVOKAMET XR

Introduction to INVOKAMET XR

INVOKAMET XR is a once-daily, fixed-dose combination therapy that combines canagliflozin (INVOKANA) and metformin hydrochloride extended-release (XR). This medication is approved by the U.S. FDA for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise to improve blood glucose control[1][2][4].

Market Approval and Launch

INVOKAMET XR was approved by the U.S. FDA in September 2016, marking a significant milestone in the treatment of type 2 diabetes. This approval was a result of Janssen's submission of a New Drug Application (NDA) to the FDA, highlighting the company's commitment to providing new treatment options for patients with type 2 diabetes[1][4].

Market Positioning

INVOKAMET XR combines two effective medicines: canagliflozin, the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor in the United States, and extended-release metformin, a commonly prescribed initial therapy for type 2 diabetes. This combination offers physicians flexibility in tailoring treatment to the needs of patients, especially those with higher A1C levels[1][2].

Prescription and Usage

Since its launch, INVOKANA (canagliflozin), a component of INVOKAMET XR, has seen significant prescription numbers, with over 9 million U.S. prescriptions. INVOKAMET XR itself is available in four dosages, providing options for different patient needs. The medication is taken once daily with the morning meal, offering convenience and ease of use[1][2].

Clinical Efficacy

Phase 3 studies have demonstrated that INVOKAMET XR significantly lowers blood sugar (A1C) levels better than metformin extended release alone when used along with diet and exercise. This combination therapy works by having canagliflozin help the kidneys lose sugar through urination and metformin decrease the amount of sugar produced by the liver and improve the body’s response to insulin[1][2].

Safety and Side Effects

While INVOKAMET XR is effective, it also comes with potential serious side effects. One of the most significant risks is lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. Patients are advised to monitor for symptoms such as muscle pain, weakness, dizziness, or shortness of breath, which could indicate lactic acidosis[1].

Financial Support and Savings Programs

To make INVOKAMET XR more accessible, Janssen offers savings and cost support programs. Eligible commercial or private patients can pay $0 per month for INVOKAMET XR, subject to monthly program benefit limits. This program includes a $200 limit for each month after the first month and a $3,000 maximum program benefit per calendar year. However, this program is not valid for patients using Medicare, Medicaid, or other government-funded programs[5].

Market Dynamics

INVOKAMET XR operates within a competitive landscape of type 2 diabetes treatments. However, its unique combination of canagliflozin and extended-release metformin positions it as a preferred option for many physicians. The medication's once-daily dosing and flexibility in treatment options contribute to its market appeal.

Competitive Landscape

The type 2 diabetes market is highly competitive, with several major pharmaceutical companies offering various treatments. INVOKAMET XR competes with other combination therapies and monotherapies, but its approval and market performance indicate a strong market presence. As the most prescribed SGLT2 inhibitor, canagliflozin's inclusion in INVOKAMET XR enhances its market dynamics[1][4].

Market Growth and Projections

Janssen's overall portfolio, including INVOKAMET XR, is expected to drive significant growth. The company projects a compound annual growth rate (CAGR) of 5-7% from 2025 to 2030, driven by market share gains and expansion into new patient populations. While specific financial projections for INVOKAMET XR are not detailed, its inclusion in Janssen's portfolio contributes to the company's overall growth strategy[3].

Financial Trajectory

Revenue Contribution

INVOKAMET XR, as part of Janssen's diabetes portfolio, contributes to the company's revenue. Although exact revenue figures for INVOKAMET XR are not publicly disclosed, the medication's market performance and the overall success of the INVOKANA franchise suggest a positive financial trajectory.

Cost and Pricing

The cost of INVOKAMET XR can vary, but the savings and cost support programs offered by Janssen help make the medication more affordable for eligible patients. The program's structure, with $0 per month for the first month and subsequent monthly limits, helps manage patient costs while ensuring revenue stability for the company[5].

Industry Expert Insights

Industry experts highlight the importance of combination therapies like INVOKAMET XR in managing type 2 diabetes. For example, John Anderson, M.D., noted that "INVOKAMET XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1C levels"[1].

Key Statistics

• Prescription Numbers: Over 9 million U.S. prescriptions for INVOKANA since its launch[1].
• Market Approval: Approved by the U.S. FDA in September 2016[1].
• Dosage Options: Available in four dosages, combining canagliflozin 50 mg or 150 mg with metformin XR 500 mg or 1000 mg[1].
• Projected Growth: Janssen's overall portfolio, including INVOKAMET XR, is expected to achieve a CAGR of 5-7% from 2025 to 2030[3].

Conclusion

INVOKAMET XR is a significant player in the type 2 diabetes treatment market, offering a convenient and effective combination therapy. Its market dynamics are strong, driven by its unique formulation and the success of its component medications. The financial trajectory for INVOKAMET XR is positive, contributing to Janssen's overall growth and revenue projections.

Key Takeaways

• Combination Therapy: INVOKAMET XR combines canagliflozin and extended-release metformin.
• Market Approval: Approved by the U.S. FDA in September 2016.
• Clinical Efficacy: Significantly lowers blood sugar (A1C) levels.
• Safety Considerations: Potential risk of lactic acidosis.
• Financial Support: Savings and cost support programs available.
• Market Growth: Contributes to Janssen's projected CAGR of 5-7% from 2025 to 2030.

FAQs

What is INVOKAMET XR used for?

INVOKAMET XR is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.

How is INVOKAMET XR taken?

INVOKAMET XR is taken once daily with the morning meal, available in four different dosage combinations.

What are the potential side effects of INVOKAMET XR?

One of the serious side effects is lactic acidosis, a rare but serious complication that can occur due to metformin accumulation.

Is INVOKAMET XR covered by savings programs?

Yes, eligible commercial or private patients can pay $0 per month for INVOKAMET XR, subject to monthly program benefit limits.

How does INVOKAMET XR compare to other type 2 diabetes treatments?

INVOKAMET XR offers a unique combination of canagliflozin and extended-release metformin, providing flexibility and convenience in treatment options.

Sources

1. Janssen Pharmaceuticals, Inc. - U.S. FDA Approves INVOKAMET® XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes.
2. INVOKANA - About INVOKAMET® & INVOKAMET® XR.
3. Johnson & Johnson - Innovative Medicine Presentation.
4. Janssen Research & Development, LLC - Janssen Submits INVOKAMET® XR (Canagliflozin / Metformin Hydrochloride Extended Release) for Approval by the U.S. FDA as an Adjunctive Treatment in Adults with Type 2 Diabetes.
5. INVOKANA - Savings and Cost Support.