Details for New Drug Application (NDA): 204353
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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
Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;500MG | ||||
Approval Date: | Aug 8, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 6, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 26, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist 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 Up | Patent Expiration: | Feb 26, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist 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 | 204353-001 | Aug 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | INVOKAMET | canagliflozin; metformin hydrochloride | TABLET;ORAL | 204353-003 | Aug 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
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 | 204353-004 | Aug 8, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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