Viewing data from:

ARNUITY ELLIPTA

NDA

FLUTICASONE FUROATE | N205625 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

3 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

Today

M-290

Mar. 1, 2026

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

417 trials from ClinicalTrials.gov — 1 recruiting, 4 active, 354 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Seal, Stopping Eczema and Allergy Study NCT03742414	Phase 2	Active	Kari Nadeau, MD, PhD	398	2021-06-30 → 2028-06-30
A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers NCT02476825	Phase 4	Active	University Hospitals, Leicester	30	2016-01-20 → 2026-10-31
The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype NCT04171167	N/A	Active	Tampere University Hospital	88	2017-04-04 → 2026-12
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
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Assessment of Fluticasone Propionate on Ocular Allergy Symptoms NCT01817790	Phase 3	Completed	GlaxoSmithKline	626	2012-12 → 2013-02
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block NCT02466503	Phase 1	Completed	Intech Biopharm Ltd.	45	2014-08 → 2014-09
Effects of Broccoli Sprout Extract on Allergy Rhinitis NCT02885025	Phase 2	Completed	VA Office of Research and Development	47	2016-10-01 → 2019-03-12
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler NCT02980133	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	841	2016-12-28 → 2019-04-13

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs (5 brand, 3 generic)

Highest NADAC/Unit

$8.91

per ea

Lowest NADAC/Unit

$4.22

per ea

Brand NDCs

Generic NDCs

Avg Brand: $7.55

Avg Generic: $4.72

38% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173087614ARNUITY ELLIPTA 200 MCG INH	$8.91	EA	Brand	—	2026-06-17
00173087610ARNUITY ELLIPTA 200 MCG INH	$8.90	EA	Brand	$5.67	2026-06-17
00173087414ARNUITY ELLIPTA 100 MCG INH	$6.67	EA	Brand	—	2026-06-17
00173087410ARNUITY ELLIPTA 100 MCG INH	$6.66	EA	Brand	$4.27	2026-06-17
00173088810ARNUITY ELLIPTA 50 MCG INH	$6.64	EA	Brand	$4.22	2026-06-17
66993016897FLUTICASONE ELLIPTA 200 MCG INH	$5.67	EA	Generic	—	2026-06-17
66993016797FLUTICASONE ELLIPTA 100 MCG INH	$4.27	EA	Generic	—	2026-06-17
66993016697FLUTICASONE ELLIPTA 50 MCG INH	$4.22	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 | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$54.46

Highest Price

$220.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0874-10ARNUITY ELLIPTA 100MCG	$164.80	FSS	GlaxoSmithKline	07/31/2027
00173-0874-10ARNUITY ELLIPTA 100MCG	$152.90	Big4	GlaxoSmithKline	07/31/2027
00173-0874-14ARNUITY ELLIPTA 100MCG	$67.57	FSS	GlaxoSmithKline	07/31/2027
00173-0874-14ARNUITY ELLIPTA 100MCG	$54.46	Big4	GlaxoSmithKline	07/31/2027
00173-0876-10ARNUITY ELLIPTA 200MCG	$220.62	FSS	GlaxoSmithKline	07/31/2027
00173-0876-10ARNUITY ELLIPTA 200MCG	$204.81	Big4	GlaxoSmithKline	07/31/2027

Showing 6 of 16 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Arnuity Ellipta (2024)

Total Spending

$199.9M

Total Claims

659,581

Beneficiaries

181,821

Avg Cost/Unit

$7.37

Spending Trend

$65.5M(2019)→$80.9M(2020)→$85.0M(2021)→$88.8M(2022)→$98.3M(2023)→$199.9M(2024)

YoY Change:-10.2%

5yr CAGR:+1.8%

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

API Supply Chain14 active DMFs1 inactive

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

STERLING SPAFLUTICASONE FUROATE

DMF 246472011

WAVELENGTH ENTERPRISES LTDFLUTICASONE FUROATE

DMF 285542014

HOVIONE FARMACIENCIA SAFLUTICASONE FUROATE INHALATION GRADE

DMF 317132017

GLAXOSMITHKLINE LLCFLUTICASONE FUROATE

DMF 319382017

CORAL DRUGS PRIVATE LTDFLUTICASONE FUROATE

DMF 320402017

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE FUROATE

DMF 336362019

AARTI PHARMALABS LTDFLUTICASONE FUROATE

DMF 339552020

CORAL DRUGS PRIVATE LTDFLUTICASONE FUROATE (PROCESS 1)

DMF 363162021

TAPI NL BVFLUTICASONE FUROATE

DMF 366212023

CIPLA LTDFLUTICASONE FUROATE

DMF 367362022

LUPIN LTDFLUTICASONE FUROATE

DMF 374652022

FARMABIOS SPAFLUTICASONE FUROATE

DMF 400902024

BREATHGREEN PHARMACEUTICAL CO LTDFLUTICASONE FUROATE (MICRONIZED AND NON-MICRONIZED)

DMF 409752024

NEWCHEM SPAFLUTICASONE FUROATE

DMF 419352025

VAMSI LABS LTDInactiveFLUTICASONE FUROATE EP

DMF 404182024

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 19, 2023	SUPPL -11	View Letter (PDF)
Mar 2, 2023	SUPPL -9	View Letter (PDF)
Feb 13, 2019	SUPPL -7	View Letter (PDF)
May 21, 2018	SUPPL -5	View Letter (PDF)
Mar 24, 2015	SUPPL -1	View Letter (PDF)
Aug 21, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.1MG/INH

RLD

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Aug 20, 2014

No patent or exclusivity listings for this strength.

#002 — 0.2MG/INH

RLD

0 patents0 exclusivities▾

POWDER;INHALATION | Approved: Aug 20, 2014

#003 — 0.05MG/INH

RLD

0 patents1 exclusivity▾

POWDER;INHALATION | Approved: May 17, 2018