FDA Orange Book · active-ingredient family
Baloxavir marboxil
Baloxavir marboxil is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XOFLUZA · NDA 214410
2
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
6
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XOFLUZARLD×3 | GENENTECH INC | NDA 214410 | — | Nov 23, 2020 | |
| XOFLUZARLD×3 | GENENTECH INC | NDA 210854 | — | Oct 24, 2018 |
Marketing exclusivity (6)
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9815835 | Jun 14, 2030 | in 4 yr 1 mo | Product |
| 8927710 | May 05, 2031 | in 4 yr 11 mo | Product |
| 8987441 | Oct 24, 2032 | in 6 yr 5 mo | SubstanceProduct |
| 10633397 | Apr 27, 2036 | in 10 yr | U-2816 |
| 10392406 | Apr 27, 2036 | in 10 yr | Substance |
| 11306106 | Aug 09, 2037 | in 11 yr 4 mo | U-2816 |
| 10759814 | Aug 09, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 11261198 | Sep 25, 2038 | in 12 yr 5 mo | Product |
| 12064438 | Oct 09, 2039 | in 13 yr 6 mo | Product |
| 11925648 | Apr 21, 2041 | in 15 yr 1 mo | Product |
Baloxavir marboxil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
