Viewing data from:

ANORO ELLIPTA

NDA

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | N203975 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (1)Active (4)TodayPED (+6 mo)

2027

2028

2029

2030

2031

Today

Dec. 18, 2027

Dec. 14, 2027

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366 NCT03378648	Phase 1/2	Completed	Chiesi Farmaceutici S.p.A.	118	2017-12-28 → 2019-04-16
A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD NCT01313637	Phase 3	Completed	GlaxoSmithKline	1,493	2011-03-01 → 2012-04-19

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (2 brand, 1 generic)

Highest NADAC/Unit

$8.03

per ea

Lowest NADAC/Unit

$4.87

per ea

Brand NDCs

Generic NDCs

Avg Brand: $7.92

Avg Generic: $4.87

38% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173086906ANORO ELLIPTA 62.5-25 MCG INH	$8.03	EA	Brand	—	2026-06-17
00173086910ANORO ELLIPTA 62.5-25 MCG INH	$7.80	EA	Brand	$4.87	2026-06-17
66993013497UMECLIDINIUM-VILANTEROL ELLIPTA 62.5-25 MCG INH	$4.87	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$55.97

Highest Price

$316.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0134-97UMECLIDINIUM 62.5MCG/VILANTEROL 25MCG/ACTUAT	$302.26	FSS	Prasco, LLC	06/30/2026
66993-0134-97UMECLIDINIUM 62.5MCG/VILANTEROL 25MCG/ACTUAT	$217.51	Big4	Prasco, LLC	06/30/2026
00173-0869-06ANORO ELLIPTA 62.5MCG/25MCG	$55.97	FSS	GlaxoSmithKline	07/31/2027
00173-0869-06ANORO ELLIPTA 62.5MCG/25MCG	$55.97	Big4	GlaxoSmithKline	07/31/2027
00173-0869-10ANORO ELLIPTA 62.5MCG/25MCG	$316.13	FSS	GlaxoSmithKline	07/31/2027
00173-0869-10ANORO ELLIPTA 62.5MCG/25MCG	$316.13	Big4	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 Anoro Ellipta (2024)

Total Spending

$819.3M

Total Claims

1,383,988

Beneficiaries

291,195

Avg Cost/Unit

$7.58

Spending Trend

$825.9M(2019)→$1.0B(2020)→$912.4M(2021)→$866.8M(2022)→$873.0M(2023)→$819.3M(2024)

YoY Change:-6.1%

5yr CAGR:+1.5%

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2023	SUPPL -15	View Letter (PDF)
Oct 21, 2022	SUPPL -13	View Letter (PDF)
Jun 26, 2019	SUPPL -10	View Letter (PDF)
Jun 4, 2019	SUPPL -9	View Letter (PDF)
Oct 19, 2017	SUPPL -7	View Letter (PDF)
Mar 24, 2017	SUPPL -5	View Letter (PDF)
Feb 26, 2016	SUPPL -3	View Letter (PDF)
Dec 20, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

RLD

5 patents0 exclusivities▴

POWDER;INHALATION | Approved: Dec 18, 2013

Patents (5) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7488827	Dec 18, 2027	—	Yes	Yes	—	—
8511304	Jun 14, 2027PED: Dec 14, 2027	PED	—	Yes		—
9750726	Nov 29, 2030	—	—	Yes	—	—
11090294	Nov 29, 2030	—	—	—		—
12396986	Nov 29, 2030	—	—	Yes	—	—