Viewing data from:

FLOVENT HFA

NDA

FLUTICASONE PROPIONATE | N021433 | GLAXO GROUP LTD DBA GLAXOSMITHKLINE

3 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Flovent HFA (2023)

Total Spending

$394.5M

Total Claims

963,296

Beneficiaries

319,369

Avg Cost/Unit

$26.97

Spending Trend

$423.0M(2019)→$463.1M(2020)→$464.9M(2021)→$445.1M(2022)→$394.5M(2023)

YoY Change:+0.5%

5yr CAGR:+2.8%

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

API Supply Chain26 active DMFs5 inactive

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

WAVELENGTH ENTERPRISES LTDFLUTICASONE PROPIONATE

DMF 154562001

TAPI NL BVFLUTICASONE PROPIONATE

DMF 157452001

CIPLA LTDFLUTICASONE PROPIONATE USP

DMF 157742001

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE

DMF 163342002

STERLING SPAFLUTICASONE PROPIONATE

DMF 164232003

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE USP

DMF 202122007

FARMABIOS SPAFLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)

DMF 204632007

CORAL DRUGS PVT LTDFLUTICASONE PROPIONATE

DMF 218792008

NEWCHEM SPAFLUTICASONE PROPIONATE MICRONIZED

DMF 222362008

AARTI PHARMALABS LTDFLUTICASONE PROPIONATE USP

DMF 229802009

INDUSTRIALE CHIMICA SRLFLUTICASONE PROPIONATE USP

DMF 234272010

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE INHALATION GRADE

DMF 247912011

LUPIN LTDFLUTICASONE PROPIONATE USP

DMF 299752015

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)

DMF 304172016

GLAXOSMITHKLINEFLUTICASONE PROPIONATE

DMF 315342017

CHONGQING HUAPONT PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE INTERMEDIATE

DMF 327832018

GLAXOSMITHKLINE LLCFLUTICASONE PROPIONATE

DMF 329522018

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS III)

DMF 331722018

TIANJIN TIANYAO PHARMACEUTICALS CO LTDFLUTICASONE PROPIONATE USP

DMF 341262019

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE (CRUDE)

DMF 342732019

SHANDONG SIRUI PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE

DMF 353592021

APOTEX INCFLUTICASONE PROPIONATE USP (MICRONIZED)

DMF 353932020

CORAL DRUGS PRIVATE LTDFLUTICASONE PROPIONATE (PROCESS 1)

DMF 363152021

CURIA SPAIN SAUFLUTICASONE PROPIONATE MICRONIZED

DMF 372972022

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

DMF 387592023

VAMSI LABS LTDFLUTICASONE PROPIONATE USP

DMF 428122025

SCINOPHARM TAIWAN LTDInactiveFLUTICASONE PROPIONATE

DMF 156862001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFLUTICASONE PROPIONATE EP/BP

DMF 175442004

NEULAND LABORATORIES LTDInactiveFLUTICASONE PROPIONATE PH.EUR

DMF 191152006

MYLAN LABORATORIES LTDInactiveFLUTICASONE PROPIONATE USP

DMF 282642014

VAMSI LABS LTDInactiveFLUTICASONE PROPIONATE EP

DMF 402852024

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2021	SUPPL -40	View Letter (PDF)
Feb 13, 2019	SUPPL -34	View Letter (PDF)
Jul 21, 2017	SUPPL -33	View Letter (PDF)
Oct 6, 2016	SUPPL -32	View Letter (PDF)
Aug 1, 2016	SUPPL -31	View Letter (PDF)
Dec 12, 2014	SUPPL -26	View Letter (PDF)
Dec 3, 2014	SUPPL -19	View Letter (PDF)
Nov 17, 2014	SUPPL -25	View Letter (PDF)
Jul 22, 2013	SUPPL -22	View Letter (PDF)
Nov 8, 2010	SUPPL -15	View Letter (PDF)
Jul 2, 2008	SUPPL -11	View Letter (PDF)
Oct 27, 2006	SUPPL -6	View Letter (PDF)
Mar 3, 2006	SUPPL -4	View Letter (PDF)
Jan 18, 2006	SUPPL -5	View Letter (PDF)
May 26, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.22MG/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: May 14, 2004

No patent or exclusivity listings for this strength.

#002 — 0.11MG/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: May 14, 2004

#003 — 0.044MG/INH

RLDAB

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: May 14, 2004

Change History (4)

Recent changes detected for this application.

REMOVED7/1/2026

Glaxo Group Ltd removed U.S. Patent No. 7,500,444 from the Orange Book listing for Flovent HFA (fluticasone propionate) NDA 021433.

Old: Record existed

REMOVED7/1/2026

FLOVENT HFA (fluticasone propionate) patent 7500444 was removed from the Orange Book.

Old: Record existed

REMOVED7/1/2026

Orange Book patent listing for FLOVENT HFA (fluticasone propionate) inhalation aerosol removed.

Old: Record existed

REMOVED7/1/2026

Orange Book patent listing for fluticasone propionate (Flovent HFA) patent 7500444 removed.

Old: Record existed