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VANCENASE AQ

NDA

BECLOMETHASONE DIPROPIONATE MONOHYDRATE | N020469 | SCHERING 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-2024-P-5664 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this petition pursuant to sections 505(j) and 505(w) of the FDC Act and 21 C.F.R. §§ 314.122 and 314.161 requesting that the FDA determine whether Vancenase 0.042 mg/INH (NDA 018521), Vancenase AQ EQ 0.042 mg DIPROP/SPRAY (NDA 019589), and Vancenase AQ EQ 0.084 m	505(q)	2024-12-09	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.

Products (1)

#001 — EQ 0.084MG DIPROP/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jun 26, 1996

No patent or exclusivity listings for this strength.