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 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 nineteen 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: | 3 |
| Formulation / Manufacturing: | see details |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for INVOKAMET XR
| 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 XR
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Glucopyranoside compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Glucopyranoside compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Glucopyranoside compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS
Glucopyranoside compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-004 | Sep 20, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-002 | Sep 20, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-004 | Sep 20, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-001 | Sep 20, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-004 | Sep 20, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVOKAMET XR | canagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879-003 | Sep 20, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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: ⤷ Try a Trial
Patent: 7510
Estimated Expiration: ⤷ Try a Trial
Patent: 8450
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07329895
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0718882
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 71357
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07003487
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1573368
Estimated Expiration: ⤷ Try a Trial
Patent: 2675299
Estimated Expiration: ⤷ Try a Trial
Patent: 2675380
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 10719
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 861
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0140254
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 14969
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 02224
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 099489
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 09003285
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7103
Estimated Expiration: ⤷ Try a Trial
Patent: 0970540
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 02224
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0900151
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 09001135
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9032
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 59788
Estimated Expiration: ⤷ Try a Trial
Patent: 10511602
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3702
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09005857
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 829
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7545
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 0900113
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 4354
Estimated Expiration: ⤷ Try a Trial
Patent: 091778
Estimated Expiration: ⤷ Try a Trial
Panama
Patent: 59401
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 081201
Estimated Expiration: ⤷ Try a Trial
Patent: 110841
Estimated Expiration: ⤷ Try a Trial
Patent: 130591
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 02224
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 02224
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 274
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 02224
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0903941
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1146095
Estimated Expiration: ⤷ Try a Trial
Patent: 090086282
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 56640
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 03325
Estimated Expiration: ⤷ Try a Trial
Patent: 0829259
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 135
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 730
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Canada | 2671357 | FORME CRISTALLINE DE 1- (.BETA.-D-GLUCOPYRANOSYL)-4 -METHYLE-2-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYLE] BENZENE HEMIHYDRATE (CRYSTALLINE FORM OF 1- (.BETA.-D-GLUCOPYRANOSYL)-4-METHYL-2-[5-(4-FLUOROPHENYL)-2-THIENYLMETHYL] BENZENE HEMIHYDRATE) | ⤷ Try a Trial |
| European Patent Office | 2896397 | Nouveaux composés présentant une activité inhibitrice contre le transporteur de glucose dépendant du sodium (Novel compounds having inhibitory activity against sodium-dependant glucose transporter) | ⤷ Try a Trial |
| Montenegro | P61208 | NOVA JEDINJENJA KOJA IMAJU INHIBITORNO DEJSTVO NA TRANSPORTER GLUKOZE ZAVISTAN OD NATRIJUMA (NOVEL COMPOUNDS HAVING INHIBITORY ACTIVITY AGAINST SODIUM-DEPENDANT TRANSPORTER) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2008069327 | ⤷ Try a Trial | |
| Poland | 2896397 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2005011592 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVOKAMET XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1651658 | 300670 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/13/884/001-008 20131119 |
| 1651658 | C01651658/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62956 29.01.2014 |
| 1651658 | 1490027-8 | Sweden | ⤷ Try a Trial | PERIOD OF VALIDITY (FROM - UNTIL): 20240731 - 20281118 |
| 1651658 | 164 1-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115 |
| 1651658 | 2014/029 | Ireland | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001-004 20131119 |
| 1651658 | CR 2014 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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