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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 five 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 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 May 11, 2031. 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:	268
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	23
Patent Applications:	1,206
Formulation / Manufacturing:	see details
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

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
University of Michigan	Phase 2
Brigham and Women's Hospital	Phase 2
University of Colorado, Denver	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

Anatomical Therapeutic Chemical (ATC) Classes for INVOKANA

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 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 nineteen 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 INVOKANA

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			Y	Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-001	Mar 29, 2013		RX	Yes	No			Y	Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes			Y
Janssen Pharms	INVOKANA	canagliflozin	TABLET;ORAL	204042-002	Mar 29, 2013		RX	Yes	Yes			Y	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

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

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
Luxembourg	92426
China	104109155	Novel Compounds
Norway	2014009
Japan	2016147866	ＳＧＬＴの阻害剤としての１−（β−Ｄ−グルコピラノシル）−２−チエニル−メチルベンゼン誘導体を含有する医薬製剤 (PHARMACEUTICAL FORMULATIONS COMPRISING 1-(β-D-GLUCOPYRANOSYL)-2-THIENYL-METHYLBENZENE DERIVATIVES AS SGLT INHIBITORS)
Montenegro	02531	FARMACEUTSKE FORMULACilE KOJE OBUHVATAJU DERIVATIVE 1 - (BE TA- D- GLUKOPIRANOZ IL)-2- TIENILMETILBENZENA KAO SGLT INHIBITORE (PHARMACEUTICAL FORMULATIONS COMPRISING 1 - (BETA-D-GLUCOPYRANOSYL) - 2 -THIENYLMETHYLBENZENE DERIVATIVES AS INHIBITORS OF SGLT)

Supplementary Protection Certificates for INVOKANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1651658	300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658	122014000050	Germany		PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1651658	CR 2014 00024	Denmark		PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119
1651658	C300670	Netherlands		PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131118
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