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 (pediatric extension).

Listed patents · 4 unexpired

12 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 8746242	drug product	11 Apr 2031	2 listing rows
US 8746242 listing row	drug product	11 Oct 2030	3 strengths · listed 9 Jun 2023
US 8746242 listing row	pediatric extension · sets the listed date	11 Apr 2031	3 strengths
US 8534281	drug product	8 Sep 2030	2 listing rows
US 8534281 listing row	drug product	8 Mar 2030	3 strengths · listed 7 May 2015
US 8534281 listing row	pediatric extension	8 Sep 2030	3 strengths
US 11116721	drug product, use U-1401, U-1691, U-3623	26 Aug 2029	4 listing rows
US 11116721 listing row	drug product, use U-1401	26 Feb 2029	listed 12 Oct 2021
US 11116721 listing row	drug product, use U-1691	26 Feb 2029	2 strengths · listed 12 Oct 2021
US 11116721 listing row	drug product, use U-3623	26 Feb 2029	3 strengths · listed 9 Jun 2023
US 11116721 listing row	pediatric extension	26 Aug 2029	3 strengths
US 8511304	drug product, use U-1424, U-1691, U-3623	14 Dec 2027	4 listing rows
US 8511304 listing row	drug product, use U-1424	14 Jun 2027	listed 6 Sep 2013
US 8511304 listing row	drug product, use U-1691	14 Jun 2027	2 strengths · listed 7 May 2015
US 8511304 listing row	drug product, use U-3623	14 Jun 2027	3 strengths · listed 7 May 2015
US 8511304 listing row	pediatric extension	14 Dec 2027	3 strengths

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

Exclusivity expires within 90 days PED · 204275-001Exclusivity expires 13 Nov 2026Detected 24 Oct 2026
Exclusivity expires within 90 days PED · 204275-003Exclusivity expires 13 Nov 2026Detected 24 Oct 2026

Products covered · 3

NDA · product	Form	Strength	Approved	Listed expiry
204275 · 001 · RLD	powder, inhalation	0.1MG/INH;EQ 0.025MG BASE/INH	10 May 2013	11 Apr 2031
204275 · 002 · RLD	powder, inhalation	0.2MG/INH;EQ 0.025MG BASE/INH	30 Apr 2015	11 Apr 2031
204275 · 003 · RLD	powder, inhalation	0.05MG/INH;EQ 0.025MG BASE/INH	12 May 2023	11 Apr 2031

Expired or delisted (2)

NPP · 13 May 2026
NS · 13 May 2026