Details for New Drug Application (NDA): 214410
✉ Email this page to a colleague
The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 214410
Tradename: | XOFLUZA |
Applicant: | Genentech Inc |
Ingredient: | baloxavir marboxil |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214410
Generic Entry Date for 214410*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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: 214410
Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 214410
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-583 | 50242-583-01 | 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 2MG/ML | ||||
Approval Date: | Nov 23, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD FOR TREATING INFLUENZA |
Complete Access Available with Subscription