baloxavir marboxil · Genentech Inc · NDA 210854, 214410
Xofluza
Other strengths are listed to 21 Apr 2041.
Blocked by patent: US 12064438.
FDA has approved 1 generic application (ANDA) for Xofluza, though its earliest generic-entry date is 9 Oct 2039 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 10 unexpired
12 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11925648 | drug product | 21 Apr 2041 |
| US 12064438 | drug product · sets the listed date | 9 Oct 2039 |
| US 11261198 | drug product | 25 Sep 2038 |
| US 10759814 | drug substance, drug product | 9 Aug 2037 |
| US 11306106 | use U-2816, U-3000 | 9 Aug 2037 |
| US 11306106 listing row | use U-2816 | 9 Aug 2037 |
| US 11306106 listing row | use U-3000 | 9 Aug 2037 |
| US 10392406 | drug substance | 27 Apr 2036 |
| US 10633397 | use U-2816, U-3000 | 27 Apr 2036 |
| US 10633397 listing row | use U-2816 | 27 Apr 2036 |
| US 10633397 listing row | use U-3000 | 27 Apr 2036 |
| US 8987441 | drug substance, drug product | 24 Oct 2032 |
| US 8927710 | drug product | 5 May 2031 |
| US 9815835 | drug product | 14 Jun 2030 |
Exclusivities · 1 unexpired
| M-187 | miscellaneous (3 years) | 19 Dec 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026First generic approved · 210854-00117 Jun 2026
- 25 Oct 2026Generic approved · 210854-00117 Jun 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210854 · 001 · RLD · discontinued | tablet, oral | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 9 Oct 2039 |
| 210854 · 002 · RLD | tablet, oral | 40MG | 9 Oct 2039 |
| 210854 · 003 · RLD | tablet, oral | 80MG | 9 Oct 2039 |
| 214410 · 001 · RLD | for suspension, oral | 2MG/ML | 21 Apr 2041 |
| 214410 · 002 · RLD | for suspension, oral | 30MG/PACKET | 21 Apr 2041 |
| 214410 · 003 · RLD | for suspension, oral | 40MG/PACKET | 21 Apr 2041 |