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-eight 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:	268
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for INVOKAMET

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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.

Patents protecting INVOKAMET

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

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
Ukraine	107578	КОМБІНОВАНА ТЕРАПІЯ ПРИ ЛІКУВАННІ ДІАБЕТУ
Israel	259475	טיפול משולב עבור טיפול בסכרת (Combination therapy for the treatment of diabetes)
Poland	1651658
Norway	20060219
South Africa	200603882	Substituted benzimidazole-, benztriazole-, and benzimidazolone-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	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	C01651658/01	Switzerland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014
1651658	2014/029	Ireland		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119
1651658	2014C/027	Belgium		PRODUCT NAME: CANAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/13/884 20131119