fluticasone furoate; vilanterol trifenatate · Glaxo Grp Ltd · NDA 204275
Breo Ellipta
Earliest generic entry, as listed · earliest of 3 marketed strengths
11 Apr 2031
Blocked by patent: US 8746242.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8746242 | — | 11 Apr 2031 |
| US 8746242 | product | 11 Oct 2030 |
| US 8534281 | — | 8 Sep 2030 |
| US 8534281 | product | 8 Mar 2030 |
| US 11116721 | — | 26 Aug 2029 |
| US 11116721 | product, use U-3623 | 26 Feb 2029 |
| US 11116721 | product, use U-1401 | 26 Feb 2029 |
| US 11116721 | product, use U-1691 | 26 Feb 2029 |
| US 8511304 | — | 14 Dec 2027 |
| US 8511304 | product, use U-3623 | 14 Jun 2027 |
| US 8511304 | product, use U-1691 | 14 Jun 2027 |
| US 8511304 | product, use U-1424 | 14 Jun 2027 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 13 Nov 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days PED · 204275-00113 Nov 2026
- 24 Oct 2026Exclusivity expires within 90 days PED · 204275-00313 Nov 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204275 · 001 · RLD | powder, inhalation | 0.1MG/INH;EQ 0.025MG BASE/INH | 11 Apr 2031 |
| 204275 · 002 · RLD | powder, inhalation | 0.2MG/INH;EQ 0.025MG BASE/INH | 11 Apr 2031 |
| 204275 · 003 · RLD | powder, inhalation | 0.05MG/INH;EQ 0.025MG BASE/INH | 11 Apr 2031 |
Expired or delisted (2)
- NPP · 13 May 2026
- NS · 13 May 2026