fluticasone propionate · Paratek Pharms · NDA 209022
Xhance
Earliest generic entry, as listed
23 Feb 2036
Blocked by patent: US 11554229, US 12616806. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
4 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11554229 | use U-2133 · sets the listed date | 23 Feb 2036 |
| US 12616806 | use U-4524, U-4525 | 23 Feb 2036 |
| US 12616806 listing row | use U-4524 · sets the listed date | 23 Feb 2036 |
| US 12616806 listing row | use U-4525 · sets the listed date | 23 Feb 2036 |
| US 12083270 | use U-2133 | 4 Apr 2031 |
Exclusivities · 1 unexpired
| I-940 | new indication (3 years) | 15 Mar 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209022 · 001 · RLD | spray, metered, nasal | 0.093MG/SPRAY | 23 Feb 2036 |