Viewing data from:

ARMONAIR RESPICLICK

NDA

FLUTICASONE PROPIONATE | N208798 | TEVA PHARMACEUTICAL INDUSTRIES LTD

8 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Aug. 14, 2031

Jun. 14, 2036

Jan. 6, 2041

Mar. 26, 2040

Feb. 20, 2040

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 Armonair Digihaler (2023)

Total Spending

$357K

Total Claims

1,038

Beneficiaries

476

Avg Cost/Unit

$297.13

Spending Trend

$42K(2021)→$76K(2022)→$357K(2023)

YoY Change:+36.2%

5yr CAGR:+6.9%

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

6 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2023	SUPPL -16	View Letter (PDF)
Apr 11, 2022	SUPPL -13	View Letter (PDF)
Jul 13, 2021	SUPPL -8	View Letter (PDF)
Sep 21, 2020	SUPPL -7	View Letter (PDF)
Mar 15, 2018	SUPPL -2	View Letter (PDF)
Jan 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#004 — 0.055MG/INH

RLD

5 patents0 exclusivities▾

POWDER;INHALATION | Approved: Feb 20, 2020

#005 — 0.113MG/INH

RLD

5 patents0 exclusivities▾

POWDER;INHALATION | Approved: Feb 20, 2020

#006 — 0.232MG/INH

RLD

5 patents0 exclusivities▾

POWDER;INHALATION | Approved: Feb 20, 2020

#008 — 0.03MG/INH

RLD

5 patents0 exclusivities▾

POWDER;INHALATION | Approved: Apr 8, 2022

#001 — 0.055MG/INH

RLD

2 patents0 exclusivities▴

POWDER;INHALATION | Approved: Jan 27, 2017

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10195375	Feb 14, 2031PED: Aug 14, 2031	PED	—	Yes	—	—
11969544	Aug 20, 2039PED: Feb 20, 2040	PED	—	Yes	—	—

#002 — 0.113MG/INH

RLD

2 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jan 27, 2017

#003 — 0.232MG/INH

RLD

2 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jan 27, 2017

#007 — 0.03MG/INH

RLD

2 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jul 9, 2021