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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204353


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NDA 204353 describes INVOKAMET, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the INVOKAMET profile page.

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.
Summary for 204353
Tradename:INVOKAMET
Applicant:Janssen Pharms
Ingredient:canagliflozin; metformin hydrochloride
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204353
Generic Entry Date for 204353*:
Constraining patent/regulatory exclusivity:
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 NDA: 204353
Suppliers and Packaging for NDA: 204353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353 NDA Janssen Pharmaceuticals, Inc. 50458-540 50458-540-60 60 TABLET, FILM COATED in 1 BOTTLE (50458-540-60)
INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353 NDA Janssen Pharmaceuticals, Inc. 50458-541 50458-541-60 60 TABLET, FILM COATED in 1 BOTTLE (50458-541-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG;500MG
Approval Date:Aug 8, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 6, 2030Product Flag?YSubstance Flag?Delist Request?
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

Expired US Patents for NDA 204353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-002 Aug 8, 2014 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-001 Aug 8, 2014 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-003 Aug 8, 2014 ⤷  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.