Viewing data from:

INCRUSE ELLIPTA

NDA

UMECLIDINIUM BROMIDE | N205382 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7488827

Dec. 18, 2027

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

20 trials from ClinicalTrials.gov, 1 active, 17 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics NCT03002389	Phase 2	Active	University of Virginia	95	2017-11-05 → 2028-01-31
A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT01822899	Phase 3	Completed	GlaxoSmithKline	717	2013-04-04 → 2013-10-07
Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks.NCT01772147	Phase 3	Completed	GlaxoSmithKline	608	2013-01 → 2013-08
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT02236611	Phase 4	Completed	GlaxoSmithKline	1,036	2014-09-26 → 2015-06-02
The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD NCT01777334	Phase 3	Completed	GlaxoSmithKline	905	2013-01-23 → 2013-09-24
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT01817764	Phase 3	Completed	GlaxoSmithKline	707	2013-03-01 → 2013-10-25
The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium NCT01899742	Phase 3	Completed	GlaxoSmithKline	497	2014-09-15 → 2015-07-22
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 Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT02164513	Phase 3	Completed	GlaxoSmithKline	10,355	2014-06-30 → 2017-07-17
A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary Disease (COPD) Using a Novel Dry Powder Inhaler (NDPI)NCT02184611	Phase 3	Completed	GlaxoSmithKline	308	2016-05-09 → 2017-11-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$11.30

per ea

Lowest NADAC/Unit

$10.28

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173087310INCRUSE ELLIPTA 62.5 MCG INH	$11.30	EA	Brand	$7.45	2026-06-17
00173087306INCRUSE ELLIPTA 62.5 MCG INH	$10.28	EA	Brand	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$35.75

Highest Price

$253.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0873-06INCRUSE ELLIPTA 62.5MCG	$35.75	FSS	GlaxoSmithKline	07/31/2027
00173-0873-06INCRUSE ELLIPTA 62.5MCG	$35.75	Big4	GlaxoSmithKline	07/31/2027
00173-0873-10INCRUSE ELLIPTA 62.5MCG	$253.57	FSS	GlaxoSmithKline	07/31/2027
00173-0873-10INCRUSE ELLIPTA 62.5MCG	$253.57	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 Incruse Ellipta (2024)

Total Spending

$375.9M

Total Claims

852,329

Beneficiaries

185,597

Avg Cost/Unit

$11.36

Spending Trend

$550.8M(2019)→$605.1M(2020)→$555.7M(2021)→$498.9M(2022)→$456.4M(2023)→$375.9M(2024)

YoY Change:-9.0%

5yr CAGR:-0.7%

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

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

GLAXOSMITHKLINE LLCUMECLIDINIUM BROMIDE

DMF 263392012

TEVA PHARMACEUTICAL INDUSTRIES LTDUMECLIDINIUM BROMIDE

DMF 329452018

HIKMA PHARMACEUTICALS LLCUMECLIDINIUM BROMIDE

DMF 354202021

INKE SAUMECLIDINIUM BROMIDE

DMF 364822023

OLON SPAUMECLIDINIUM BROMIDE

DMF 376802023

LUPIN LTDUMECLIDINIUM BROMIDE

DMF 382952023

MELODY HEALTHCARE PVT LTDUMECLIDINIUM BROMIDE

DMF 383792023

STERLING CHEMICAL MALTA LTDUMECLIDINIUM BROMIDE

DMF 398432024

CIPLA LTDUMECLIDINIUM BROMIDE

DMF 435342026

CIPLA LTDInactiveUMECLIDINIUM BROMIDE

DMF 380022023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2023	SUPPL -13	View Letter (PDF)
Jun 7, 2019	SUPPL -10	View Letter (PDF)
Oct 23, 2017	SUPPL -8	View Letter (PDF)
Jun 16, 2017	SUPPL -6	View Letter (PDF)
Feb 26, 2016	SUPPL -2	View Letter (PDF)
May 1, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.0625MG BASE/INH

RLD

1 patent0 exclusivities▴

POWDER;INHALATION | Approved: Apr 30, 2014

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7488827	Dec 18, 2027	—	Yes	Yes	—	—