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VANCERIL

NDA

BECLOMETHASONE DIPROPIONATE | N017573 | SCHERING CORP SUB SCHERING PLOUGH CORP

1 strength0 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-1598 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether Vanceril 0.042 mg/INH, approved under NDA 017573 and held by Schering-Plough Corp., was withdrawn for reasons of safety or effectiveness. The petitioner contends the drug was discontinued for commercial reas	505(q)	2025-06-06	Open	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

99 trials from ClinicalTrials.gov, 78 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma NCT00862264	Phase 3	Completed	Chiesi Farmaceutici S.p.A.	286	2004-08 → 2005-09
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone NCT01113489	Phase 3	Completed	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy	32	2010-04 → 2010-07
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)NCT01134705	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	474	2010-05 → 2010-10
Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients NCT01577082	Phase 3	Completed	Chiesi Farmaceutici S.p.A.	542	2012-04-20 → 2012-11-29
A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps NCT00788463	Phase 2	Completed	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	30	2006-11-23 → 2011-11-30
Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)NCT00861926	Phase 3	Completed	Chiesi Farmaceutici S.p.A.	1,714	2009-03-20 → 2010-12-07
(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)NCT00394329	Phase 3	Completed	Milton S. Hershey Medical Center	288	2006-11 → 2011-12
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children NCT01584492	Phase 2	Completed	Chiesi Farmaceutici S.p.A.	59	2011-12 → 2013-02
Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)NCT01783548	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	547	2013-01 → 2013-10
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma NCT02031640	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	1,113	2013-12 → 2014-12

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

API Supply Chain5 active DMFs10 inactive

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

TAPI NL BVBECLOMETHASONE DIPROPIONATE

DMF 48711983

FARMABIOS SPABECLOMETHASONE DIPROPIONATE

DMF 128131998

AMPHASTAR NANJING PHARMACEUTICALS INCBECLOMETHASONE DIPROPIONATE

DMF 278372014

SYMBIOTEC PHARMALAB PRIVATE LTDBECLOMETHASONE DIPROPIONATE USP (MICRONIZED & NON-MICRONIZED)

DMF 281372014

CIPLA LTDBECLOMETHASONE DIPROPIONATE USP (ANHYDROUS)

DMF 289282015

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 60841985

QUATRUMInactiveBECLOMETHASONE DIPROPIONATE

DMF 75011988

ROUSSELL UCLAFInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 80361989

FARMABOISInactiveBECLOMETHASONE DIPROPIONATE

DMF 80761989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE

DMF 139651999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveBECLOMETHASONE DIPROPIONATE ANHYDROUS, BULK DRUG SUBSTANCE

DMF 169342003

CIPLA LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 197502006

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBECLOMETHASONE DIPROPIONATE USP

DMF 226482008

ALP PHARM BEIJING CO LTDInactiveBECLOMETHASONE DIPROPIONATE

DMF 230302009

HOVIONE FARMACIENCIA SAInactiveBECLOMETHASONE DIPROPIONATE MONOHYDRATE USP

DMF 271962013

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

Products (1)

#001 — 0.042MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.