Viewing data from:

ASMANEX TWISTHALER

NDA

MOMETASONE FUROATE | N021067 | ORGANON LLC

2 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

154 trials from ClinicalTrials.gov, 126 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)NCT00358527	Phase 4	Completed	Organon and Co	401	2006-05 → 2006-11
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)NCT02478398	Phase 3	Completed	Merck Sharp & Dohme LLC	1,025	2015-07-20 → 2018-11-19
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers NCT00418509	Phase 1	Completed	Novartis	24	2006-11
Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)NCT00424008	Phase 3	Completed	Organon and Co	722	2007-04 → 2008-11
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma NCT00556673	Phase 2	Completed	Novartis	31	2007-10 → 2008-04
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma NCT00557440	Phase 2	Completed	Novartis	37	2007-11 → 2008-04
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)NCT00817050	Phase 4	Completed	Organon and Co	100	2004-12-01 → 2005-01-01
Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)NCT00666679	Phase 2	Completed	Organon and Co	134	2008-05 → 2009-02
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)NCT00383721	Phase 3	Completed	Organon and Co	1,196	2006-09 → 2010-07
Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)NCT00552110	Phase 2	Completed	Organon and Co	707	2007-07 → 2008-02

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs

Highest NADAC/Unit

$161.46

per ea

Lowest NADAC/Unit

$36.98

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206011401ASMANEX TWISTHALR 220 MCG #120	$161.46	EA	Brand	—	2026-06-17
78206011402ASMANEX TWISTHALER 220 MCG #60	$112.67	EA	Brand	—	2026-06-17
78206011404ASMANEX TWISTHALER 220 MCG #30	$96.00	EA	Brand	—	2026-06-17
78206011501ASMANEX TWISTHALER 110 MCG #30	$88.90	EA	Brand	—	2026-06-17
78206011403ASMANEX TWISTHALER 220 MCG #14	$36.98	EA	Brand	—	2026-04-22

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$24.17

Highest Price

$169.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0114-01ASMANEX TWISTHALER 220MCG	$169.74	FSS	Organon LLC	01/14/2027
78206-0114-01ASMANEX TWISTHALER 220MCG	$124.07	Big4	Organon LLC	01/14/2027
78206-0114-02ASMANEX TWISTHALER 220MCG	$118.44	FSS	Organon LLC	01/14/2027
78206-0114-02ASMANEX TWISTHALER 220MCG	$86.86	Big4	Organon LLC	01/14/2027
78206-0114-03ASMANEX TWISTHAILER 220MCG	$38.94	FSS	Organon LLC	01/14/2027
78206-0114-03ASMANEX TWISTHAILER 220MCG	$24.17	Big4	Organon LLC	01/14/2027

Showing 6 of 10 NDCs.

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

API Supply Chain33 active DMFs3 inactive

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

TAPI NL BVMOMETASONE FUROATE USP

DMF 150632000

WAVELENGTH ENTERPRISES LTDMOMETASONE FUROATE

DMF 151872000

STERLING SPAMOMETASONE FUROATE

DMF 166482003

SYMBIOTEC PHARMALAB PRIVATE LTDMOMETASONE FUROATE USP (MICRONISED)

DMF 206842007

AURISCO PHARMACEUTICAL CO LTDMOMETASONE FUROATE USP, NON-STERILE BULK

DMF 211412007

AARTI PHARMALABS LTDMOMETASONE FUROATE

DMF 213342008

HALCYON LABS PRIVATE LTDMOMETASONE FUROATE USP

DMF 216542008

NEWCHEM SPAMOMETASONE FUROATE MICRONIZED

DMF 219932008

FARMABIOS SPAMOMETASONE FUROATE

DMF 223192008

TARO PHARMACEUTICAL INDUSTRIES LTDMOMETASONE FUROATE USP/PH EUR MICRONIZED

DMF 235022010

WAVELENGTH ENTERPRISES LTDMOMETASONE FUROATE MONOHYDRATE

DMF 238882010

CURIA SPAIN SAUMOMETASONE FUROATE MICRONIZED

DMF 239162010

AARTI PHARMALABS LTDMOMETASONE FUROATE MONOHYDRATE

DMF 239772010

SYMBIOTEC PHARMALAB PRIVATE LTDMOMETASONE FUROATE MONOHYDRATE

DMF 254482011

HOVIONE FARMACIENCIA SAMOMETASONE FUROATE MONOHYDRATE INHALATION GRADE

DMF 259872012

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDMOMETASONE FUROATE

DMF 261532012

STERLING SPAMOMETASONE FUROATE MONOHYDRATE (D90<10UM)

DMF 270222013

CIPLA LTDMOMETASONE FUROATE MONOHYDRATE

DMF 272442013

AARTI PHARMALABS LTDMOMETASONE FUROATE MONOHYDRATE

DMF 279562014

CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE

DMF 308522016

CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE MONOHYDRATE

DMF 310762016

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMOMETASONE FUROATE USP BULK API

DMF 313622017

AARTI PHARMALABS LTDMOMETASONE FUROATE USP (ALTERNATE PROCESS)

DMF 331742018

FARMABIOS SPAMOMETASONE FUROATE (ALTERNATE PROCESS)

DMF 334462019

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMOMETASONE FUROATE MONOHYDRATE BULK API

DMF 341122019

INDUSTRIALE CHIMICA SRLMOMETASONE FUROATE

DMF 350092020

CORAL DRUGS PVT LTDMOMETASONE FUROATE USP (PROCESS I)

DMF 356862021

HENAN LIHUA PHARMACEUTICAL CO LTDMOMETASONE FUROATE

DMF 361822021

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

DMF 393022023

BREATHGREEN PHARMACEUTICAL CO LTDMOMETASONE FUROATE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)

DMF 393032023

HENAN LIHUA PHARMACEUTICAL CO LTDMOMETASONE FUROATE PRECESS B

DMF 404072024

CIPLA LTDMOMETASONE FUROATE USP

DMF 413552025

NEWCHEM SPAMOMETASONE FUROATE MONOHYDRATE MICRONISED

DMF 423442025

SYMBIOTEC PHARMALAB PRIVATE LTDInactiveMOMETASONE FUROATE

DMF 197812006

CIPLA LTDInactiveMOMETASONE FUROATE MONOHYDRATE

DMF 209692007

HUNAN YUXIN PHARMACEUTICAL CO LTDInactiveMOMETASONE FUROATE

DMF 259582012

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 17, 2021	SUPPL -32	View Letter (PDF)
Dec 23, 2019	SUPPL -29	View Letter (PDF)
Mar 29, 2018	SUPPL -26	View Letter (PDF)
Mar 29, 2018	SUPPL -28	View Letter (PDF)
Sep 21, 2010	SUPPL -13	View Letter (PDF)
Sep 2, 2010	SUPPL -3	View Letter (PDF)
Feb 29, 2008	SUPPL -7	View Letter (PDF)
Mar 31, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.22MG/INH

RLD

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Mar 30, 2005

No patent or exclusivity listings for this strength.

#002 — 0.11MG/INH

RLD

0 patents0 exclusivities▾

POWDER;INHALATION | Approved: Feb 1, 2008