umeclidinium bromide; vilanterol trifenatate · Glaxosmithkline · NDA 203975
Anoro Ellipta
Earliest generic entry, as listed
29 Nov 2030
Blocked by patent: US 11090294, US 12396986, US 9750726.
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11090294 | use U-3203 · sets the listed date | 29 Nov 2030 |
| US 12396986 | drug product · sets the listed date | 29 Nov 2030 |
| US 9750726 | drug product · sets the listed date | 29 Nov 2030 |
| US 7488827 | drug substance, drug product | 18 Dec 2027 |
| US 8511304 | drug product, use U-1476 | 14 Dec 2027 |
| US 8511304 listing row | drug product, use U-1476 | 14 Jun 2027 |
| US 8511304 listing row | pediatric extension | 14 Dec 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 203975 · 001 · RLD | powder, inhalation | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 29 Nov 2030 |