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Last Updated: May 27, 2022

INVOKAMET XR Drug Patent Profile


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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 twenty-two 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. Two suppliers are 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 twenty-four 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

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Drug patent expirations by year for INVOKAMET XR
Drug Prices for INVOKAMET XR

See drug prices for INVOKAMET XR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for INVOKAMET XR
Generic Entry Date for INVOKAMET XR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INVOKAMET XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 XR

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS

Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Glucopyranoside compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-001 Sep 20, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-004 Sep 20, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-001 Sep 20, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 205879-001 Sep 20, 2016 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-003 Sep 20, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 4099
Estimated Expiration: See Plans and Pricing

Patent: 7510
Estimated Expiration: See Plans and Pricing

Patent: 8450
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07329895
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0718882
Estimated Expiration: See Plans and Pricing

Canada

Patent: 71357
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07003487
Estimated Expiration: See Plans and Pricing

China

Patent: 1573368
Estimated Expiration: See Plans and Pricing

Patent: 2675299
Estimated Expiration: See Plans and Pricing

Patent: 2675380
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 10719
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 861
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140254
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14969
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 02224
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 099489
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 09003285
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7103
Estimated Expiration: See Plans and Pricing

Patent: 0970540
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 02224
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0900151
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 09001135
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9032
Estimated Expiration: See Plans and Pricing

Japan

Patent: 59788
Estimated Expiration: See Plans and Pricing

Patent: 10511602
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3702
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09005857
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 829
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7545
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0900113
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4354
Estimated Expiration: See Plans and Pricing

Patent: 091778
Estimated Expiration: See Plans and Pricing

Panama

Patent: 59401
Estimated Expiration: See Plans and Pricing

Peru

Patent: 081201
Estimated Expiration: See Plans and Pricing

Patent: 110841
Estimated Expiration: See Plans and Pricing

Patent: 130591
Estimated Expiration: See Plans and Pricing

Poland

Patent: 02224
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 02224
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 274
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 02224
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0903941
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1146095
Estimated Expiration: See Plans and Pricing

Patent: 090086282
Estimated Expiration: See Plans and Pricing

Spain

Patent: 56640
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 03325
Estimated Expiration: See Plans and Pricing

Patent: 0829259
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 135
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 730
Estimated Expiration: See Plans and Pricing

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
Brazil PI0718882 FORMA CRISTALINA DE HEMI-HIDRATO DE 1-(BETA-D-GLICOPIRANOSIL)-4-METIL-3-[5-(4-FLUORFENIL)-2-TI ENILMETIL]BENZENO See Plans and Pricing
Serbia 53274 KRISTALNI OBLIK 1-(β-D-GLUKOPIRANOZIL)-4-METIL-3-[5-(4-FLUORFENIL)-2-TIENILMETIL]BENZEN HEMIHIDRAT (CRYSTALLINE FORM OF 1- (SS-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL]BENZENE HEMIHYDRATE) See Plans and Pricing
Colombia 6210719 FORMA CRIATALINA DEL HEMIHIDRATO DE 1-(BETA-DGLUCOPIRANOSIL )-4-METIL-3-[5-(4-FLUOROFENIL)-2-TIENILMETIL]BENCENO See Plans and Pricing
Hong Kong 1086277 NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDANT TRANSPORTER See Plans and Pricing
Norway 20091778 See Plans and Pricing
Costa Rica 11263 COMPUESTOS NOVEDOSOS QUE POSEEN ACTIVIDAD INNHIBITORIA CONTRA TRANSPORTADOR DE GLUCOSA DEPENDIENTE DE SODIO (Solicitud divisional) See Plans and Pricing
Eurasian Patent Organization 200601555 ЗАМЕЩЕННЫЕ ИНДАЗОЛ-О-ГЛЮКОЗИДЫ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVOKAMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1651658 SPC/GB14/032 United Kingdom See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTERED: UK EU/1/13/884/001 20131119; UK EU/1/13/884/002 20131119; UK EU/1/13/884/003 20131119; UK EU/1/13/884/004 20131119; UK EU/1/13/884/005 20131119; UK EU/1/13/884/006 20131119; UK EU/1/13/884/007 20131119; UK EU/1/13/884/008 20131119
1651658 CA 2014 00024 Denmark See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN, HERUNDER CANAGLIFLOZINHEMIHYDRAT; REG. NO/DATE: EU/1/13/884/001-008 20131115
1651658 164 1-2014 Slovakia See Plans and Pricing PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658 C 2014 017 Romania See Plans and Pricing 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 14C0034 France See Plans and Pricing PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119
1651658 122014000050 Germany See Plans and Pricing PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1 /13/884/001-008 20131115
1651658 PA2014008 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Moodys
AstraZeneca
McKesson
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.