Viewing data from:

ARNUITY ELLIPTA

NDA

FLUTICASONE FUROATE | N205625 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

3 strengths1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2026

2027

2028

2029

2030

2031

Today

RE51082

Oct. 11, 2030

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

431 trials from ClinicalTrials.gov — 7 recruiting, 9 active, 358 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma NCT06372496	Phase 4	Active	GlaxoSmithKline	1,358	2024-04-16 → 2027-06-14
Evaluation of the Adjunctive Effects of Moxibustion in the Treatment of Cold-Syndrome Allergic Rhinitis NCT07537439	N/A	Active	University of Medicine and Pharmacy at Ho Chi Minh City	60	2026-03-01 → 2026-10-01
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
Dymista in Chinese Adolescents NCT07597473	Phase 4	Active	Viatris Inc.	100	2026-05-08 → 2026-10
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
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma NCT06664619	Phase 3	Active	Teva Branded Pharmaceutical Products R&D LLC	649	2024-12-12 → 2026-11-02
Seal, Stopping Eczema and Allergy Study NCT03742414	Phase 2	Active	Kari Nadeau, MD, PhD	398	2021-06-30 → 2028-06-30
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma NCT06676319	Phase 2	Active	Sanofi	556	2024-11-07 → 2027-07-19
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
Efficacy and Safety of Fluticasone Propionate Nebulized Suspension for Wheezing Diseases in Infants Aged 0-24 Months NCT07675252	Phase 4	Not Yet Recruiting	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	240	2026-08-01 → 2027-06-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 8 NDCs (5 brand, 3 generic)

Highest NADAC/Unit

$8.90

per ea

Lowest NADAC/Unit

$4.25

per ea

Brand NDCs

Generic NDCs

Avg Brand: $7.55

Avg Generic: $4.76

37% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173087614ARNUITY ELLIPTA 200 MCG INH	$8.90	EA	Brand	—	2026-10-21
00173087610ARNUITY ELLIPTA 200 MCG INH	$8.89	EA	Brand	$5.73	2026-10-21
00173087414ARNUITY ELLIPTA 100 MCG INH	$6.65	EA	Brand	—	2026-10-21
00173088810ARNUITY ELLIPTA 50 MCG INH	$6.65	EA	Brand	$4.25	2026-10-21
00173087410ARNUITY ELLIPTA 100 MCG INH	$6.65	EA	Brand	$4.29	2026-10-21
66993016897FLUTICASONE ELLIPTA 200 MCG INH	$5.73	EA	Generic	—	2026-10-21
66993016797FLUTICASONE ELLIPTA 100 MCG INH	$4.29	EA	Generic	—	2026-10-21
66993016697FLUTICASONE ELLIPTA 50 MCG INH	$4.25	EA	Generic	—	2026-10-21

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
66993-0166-97FLUTICASONE FUROATE 50MCG/ACTUAT INHL,ORAL,30	$99.82	Big4	Prasco, LLC	06/30/2026
66993-0166-97FLUTICASONE FUROATE 50MCG/ACTUAT INHL,ORAL,30	$134.85	FSS	Prasco, LLC	06/30/2026
66993-0167-97FLUTICASONE FUROATE 100MCG/ACTUAT INHL,ORAL	$99.43	Big4	Prasco, LLC	06/30/2026
66993-0167-97FLUTICASONE FUROATE 100MCG/ACTUAT INHL,ORAL	$134.85	FSS	Prasco, LLC	06/30/2026
66993-0168-97FLUTICASONE FUROATE 200MCG/ACTUAT INHL,ORAL	$133.18	Big4	Prasco, LLC	06/30/2026
66993-0168-97FLUTICASONE FUROATE 200MCG/ACTUAT INHL,ORAL	$180.54	FSS	Prasco, LLC	06/30/2026

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

NEWCHEM SPAFLUTICASONE FUROATE

DMF 419352025

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

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

1 patent0 exclusivities▴

POWDER;INHALATION | Approved: Aug 20, 2014

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE51082Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Oct 11, 2030	—	—	Yes	—	—

#002 — 0.2MG/INH

RLD

1 patent0 exclusivities▾

POWDER;INHALATION | Approved: Aug 20, 2014

#003 — 0.05MG/INH

RLD

1 patent1 exclusivity▾

POWDER;INHALATION | Approved: May 17, 2018