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.
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: | ⤷ Try a Trial | Patent Expiration: | Jul 6, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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 | ||||||||
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