Viewing data from:

TRELEGY ELLIPTA

NDA

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | N209482 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

2 strengths7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)TodayPED (+6 mo)

2027

2028

2029

2030

2031

Today

Oct. 11, 2030

Dec. 18, 2027

Sep. 8, 2030

Apr. 11, 2031

Nov. 29, 2030

Nov. 29, 2030

Nov. 29, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED et al v. TRANSPIRE BIO INC. 0:2026cv61712 4 patentsANDA 221261fluticasone furoate, umeclidinium, vilanterol	S.D. Fla.	2026-06-16	Active	—
GlaxoSmithKline Intellectual Property Development Limited et al v. Transpire Bio Inc. 1:2026cv21512 5 patentsANDA 220811fluticasone furoate, umeclidinium, vilanterol	S.D. Fla.	2026-03-06	Terminated 2026-03-10	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma NCT06372496	Phase 4	Active	GlaxoSmithKline	1,358	2024-04-16 → 2027-06-14

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$11.20

per ea

Lowest NADAC/Unit

$11.09

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173089314TRELEGY ELLIPTA 200-62.5-25	$11.20	EA	Brand	—	2026-10-21
00173089310TRELEGY ELLIPTA 200-62.5-25	$11.15	EA	Brand	—	2026-10-21
00173088710TRELEGY ELLIPTA 100-62.5-25	$11.15	EA	Brand	—	2026-10-21
00173088714TRELEGY ELLIPTA 100-62.5-25	$11.09	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$168.85

Highest Price

$636.80

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0887-10TRELEGY ELLIPTA 100MCG/62.5MCG/25MCG	$492.58	Big4	GlaxoSmithKline	07/31/2027
00173-0887-10TRELEGY ELLIPTA 100MCG/62.5MCG/25MCG	$548.66	FSS	GlaxoSmithKline	07/31/2027
00173-0887-14TRELEGY ELLIPTA 100MCG/62.5MCG/25MCG	$168.85	Big4	GlaxoSmithKline	07/31/2027
00173-0887-14TRELEGY ELLIPTA 100MCG/62.5MCG/25MCG	$174.35	FSS	GlaxoSmithKline	07/31/2027
00173-0893-10TRELEGY ELLIPTA 200MCG/62.5MCG/25MCG	$492.90	Big4	GlaxoSmithKline	07/31/2027
00173-0893-10TRELEGY ELLIPTA 200MCG/62.5MCG/25MCG	$636.80	FSS	GlaxoSmithKline	07/31/2027
00173-0893-14TRELEGY ELLIPTA 200MCG/62.5MCG/25MCG	$170.24	Big4	GlaxoSmithKline	07/31/2027
00173-0893-14TRELEGY ELLIPTA 200MCG/62.5MCG/25MCG	$174.35	FSS	GlaxoSmithKline	07/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Trelegy Ellipta (2024)

Total Spending

$5.3B

Total Claims

6,250,872

Beneficiaries

1,268,914

Avg Cost/Unit

$10.52

Spending Trend

$821.4M(2019)→$1.5B(2020)→$2.4B(2021)→$3.3B(2022)→$4.5B(2023)→$5.3B(2024)

YoY Change:-5.9%

5yr CAGR:+2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2023	SUPPL -18	View Letter (PDF)
Dec 5, 2022	SUPPL -16	View Letter (PDF)
May 12, 2022	SUPPL -13	View Letter (PDF)
Sep 10, 2020	SUPPL -10	View Letter (PDF)
Sep 10, 2020	SUPPL -11	View Letter (PDF)
May 16, 2019	SUPPL -5	View Letter (PDF)
Feb 13, 2019	SUPPL -3	View Letter (PDF)
Apr 24, 2018	SUPPL -1	View Letter (PDF)
Sep 22, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

RLD

7 patents0 exclusivities▴

POWDER;INHALATION | Approved: Sep 18, 2017

Patents (7) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE51082Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Oct 11, 2030	—	—	Yes	—	—
7488827	Dec 18, 2027	—	Yes	Yes	—	—
8534281	Mar 8, 2030PED: Sep 8, 2030	PED	—	Yes	—	—
8746242	Oct 11, 2030PED: Apr 11, 2031	PED	—	Yes	—	—
9750726	Nov 29, 2030	—	—	Yes	—	—
11090294	Nov 29, 2030	—	—	—		—
12396986	Nov 29, 2030	—	—	Yes	—	—

#002 — 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: Sep 9, 2020