Orange Book product · Brand (NDA)
XOFLUZA
BALOXAVIR MARBOXIL
At a glance
May 30, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2025
1 yr 1 mo ago
Today
Exclusivity ends · M-187
New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
Patent 9815835 expires
Listed drug product patent expiration.
Jun 14, 2030
in 4 yr 1 mo
Patent 8927710 expires
Listed drug product patent expiration.
May 05, 2031
in 4 yr 11 mo
Patent 8987441 expires
Listed drug substance patent expiration.
Oct 24, 2032
in 6 yr 5 mo
Patent 10392406 expires
Listed drug substance patent expiration.
Apr 27, 2036
in 10 yr
Patent 10633397 expires
Listed method-of-use patent (U-3000) expiration.
Apr 27, 2036
in 10 yr
Patent 10633397 expires
Listed method-of-use patent (U-2816) expiration.
Apr 27, 2036
in 10 yr
Patent 10759814 expires
Listed drug substance patent expiration.
Aug 09, 2037
in 11 yr 4 mo
Patent 11306106 expires
Listed method-of-use patent (U-2816) expiration.
Aug 09, 2037
in 11 yr 4 mo
Patent 11306106 expires
Listed method-of-use patent (U-3000) expiration.
Aug 09, 2037
in 11 yr 4 mo
Patent 11261198 expires
Listed drug product patent expiration.
Sep 25, 2038
in 12 yr 5 mo
Patent 11925648 expires
Listed drug product patent expiration.
Apr 21, 2041
in 15 yr 1 mo
Pharmaceutical detail
Active ingredient
BALOXAVIR MARBOXIL
Strength
40MG/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 214410
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-187New use / labeling-change exclusivity (3 years)
Dec 19, 2027
in 1 yr 6 mo
Listed patents (11)
| 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 |
| 10392406 | Apr 27, 2036 | in 10 yr | Substance |
| 10633397 | Apr 27, 2036 | in 10 yr | U-3000 |
| 10633397 | Apr 27, 2036 | in 10 yr | U-2816 |
| 10759814 | Aug 09, 2037 | in 11 yr 4 mo | SubstanceProduct |
| 11306106 | Aug 09, 2037 | in 11 yr 4 mo | U-2816 |
| 11306106 | Aug 09, 2037 | in 11 yr 4 mo | U-3000 |
| 11261198 | Sep 25, 2038 | in 12 yr 5 mo | Product |
| 11925648 | Apr 21, 2041 | in 15 yr 1 mo | Product |
