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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Perioperative Bronchodilator in COPD Patients Undergoing Lung Cancer Surgery NCT04536675	Phase 3	Active	Samsung Medical Center	204	2021-04-01 → 2026-09

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

Medicare Part D Spending

CMS annual spending data for Incruse Ellipta (2023)

Total Spending

$456.4M

Total Claims

949,429

Beneficiaries

201,618

Avg Cost/Unit

$12.48

Spending Trend

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

YoY Change:+0.8%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs1 inactive

8 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 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	—	—