Details for New Drug Application (NDA): 204042
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NDA 204042 describes INVOKANA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INVOKANA profile page.
The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.
The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.
Summary for 204042
| Tradename: | INVOKANA |
| Applicant: | Janssen Pharms |
| Ingredient: | canagliflozin |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204042
Generic Entry Date for 204042*:
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: 204042
| Mechanism of Action | P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 204042
Suppliers and Packaging for NDA: 204042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INVOKANA | canagliflozin | TABLET;ORAL | 204042 | NDA | A-S Medication Solutions | 50090-4364 | 50090-4364-0 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-4364-0) |
| INVOKANA | canagliflozin | TABLET;ORAL | 204042 | NDA | A-S Medication Solutions | 50090-5029 | 50090-5029-0 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5029-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Mar 29, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 18, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 7,943,582*PED | Patent Expiration: | Aug 26, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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