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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Arnuity Ellipta (2023)

Total Spending

$98.3M

Total Claims

289,514

Beneficiaries

74,815

Avg Cost/Unit

$8.21

Spending Trend

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

YoY Change:+7.9%

5yr CAGR:+5.2%

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