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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Anoro Ellipta (2023)

Total Spending

$873.0M

Total Claims

1,390,293

Beneficiaries

294,512

Avg Cost/Unit

$8.07

Spending Trend

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

YoY Change:+3.8%

5yr CAGR:+3.9%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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	—	—