fluticasone furoate; umeclidinium bromide; vilanterol trifenatate · Glaxosmithkline · NDA 209482
Trelegy Ellipta
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Apr 2031
Blocked by patent: US 8746242 (pediatric extension).
Listed patents · 6 unexpired
8 Orange Book listing rows for 6 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8746242 | drug product | 11 Apr 2031 |
| US 8746242 listing row | drug product | 11 Oct 2030 |
| US 8746242 listing row | pediatric extension · sets the listed date | 11 Apr 2031 |
| US 11090294 | use U-3202 | 29 Nov 2030 |
| US 12396986 | drug product | 29 Nov 2030 |
| US 9750726 | drug product | 29 Nov 2030 |
| US 8534281 | drug product | 8 Sep 2030 |
| US 8534281 listing row | drug product | 8 Mar 2030 |
| US 8534281 listing row | pediatric extension | 8 Sep 2030 |
| US 7488827 | drug substance, drug product | 18 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209482 · 001 · RLD | powder, inhalation | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 11 Apr 2031 |
| 209482 · 002 · RLD | powder, inhalation | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | 11 Apr 2031 |