Details for New Drug Application (NDA): 210854
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NDA 210854 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the XOFLUZA profile page.
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.
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 210854
| Tradename: | XOFLUZA |
| Applicant: | Genentech Inc |
| Ingredient: | baloxavir marboxil |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210854
Generic Entry Date for 210854*:
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: 210854
| Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 210854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-583 | 50242-583-01 | 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 50 mL in 1 BOTTLE, GLASS |
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-01 | 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Oct 24, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 24, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 16, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 48 HOURS AND ARE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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