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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 205879


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NDA 205879 describes INVOKAMET XR, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the INVOKAMET XR profile page.

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.
Summary for 205879
Tradename:INVOKAMET XR
Applicant:Janssen Pharms
Ingredient:canagliflozin; metformin hydrochloride
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205879
Generic Entry Date for 205879*:
Constraining patent/regulatory exclusivity:
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 NDA: 205879
Suppliers and Packaging for NDA: 205879
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-940 50458-940-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01)
INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 NDA Janssen Pharmaceuticals, Inc. 50458-941 50458-941-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength50MG;500MG
Approval Date:Sep 20, 2016TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 26, 2029Product Flag?YSubstance Flag?YDelist Request?
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
Patent:⤷  Sign UpPatent Expiration:Feb 26, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
Patent:⤷  Sign UpPatent Expiration:Feb 26, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TYPE 2 DIABETES MELLITUS

Expired US Patents for NDA 205879

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

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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.