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VALISONE

NDA

BETAMETHASONE VALERATE | N016932 | 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Olsson, Frank and Weeda, P.C. FDA-2006-P-0535 · 5 docket documents The law firm Olsson, Frank and Weeda, P.C. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to submit an abbreviated new drug application (ANDA) for betamethasone valerate foam (non-aerosol), 0.12%, a non-propellant pump-del	Other	2008-12-16	Withdrawn	Olsson, Frank and Weeda, P.C.

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

Clinical Trials

140 trials from ClinicalTrials.gov — 1 recruiting, 93 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study NCT04207931	Phase 4	Recruiting	Wake Forest University Health Sciences	250	2018-04-30 → 2027-03
Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of NCT02114021	Phase 3	Completed	Tehran University of Medical Sciences	99	2012-03 → 2013-03
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema NCT00576550	Phase 4	Completed	ACO Hud Nordic AB	53	2007-10 → 2008-05
Antenatal Corticoid Therapy for Late Preterm Babies NCT00675246	N/A	Completed	Instituto Materno Infantil Prof. Fernando Figueira	320	2008-05 → 2010-05
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test NCT03004339	Phase 1	Completed	DFB Soria, LLC	13	2016-08 → 2017-02-13
A Trial That Compound Clobetasol Propionate Ointment Treats Patients With Mild to Moderate Psoriasis Vulgaris.NCT02733874	Phase 4	Completed	First Hospital of China Medical University	240	2015-04
Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata NCT02350023	Phase 4	Completed	Post Graduate Institute of Medical Education and Research, Chandigarh	50	2014-09 → 2015-03
A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)NCT02376049	Phase 1	Completed	LEO Pharma	30	2015-02 → 2015-07
India Dexamethasone and Betamethasone NCT03668860	Phase 1	Completed	Children's Hospital Medical Center, Cincinnati	48	2018-09-20 → 2019-12-31
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery NCT02744495	Phase 3	Completed	Hôpital Privé de Parly II - Le Chesnay	502	2016-02 → 2016-12

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

API Supply Chain6 active DMFs8 inactive

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

TAPI NL BVBETAMETHASONE VALERATE

DMF 41181981

FARMABIOS SPABETAMETHASONE VALERATE

DMF 127491997

HALCYON LABS PRIVATE LTDBETAMETHASONE VALERATE USP

DMF 213202008

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE VALERATE, USP (MICRONIZED)

DMF 220622008

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 358652022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 380632023

GLAXOCHEM LTDInactiveBETAMETHASONE VALERATE

DMF 45781982

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE VALERATE USP XX

DMF 54651984

DIOSYNTH BVInactiveBETAMETHASONE VALERATE

DMF 55541984

SCHERING AGInactiveBETAMETHASONE VALERATE

DMF 58631985

PFIZER INCInactiveBETAMETHASONE VALERATE

DMF 64051986

QUATRUMInactiveBETAMETHASONE VALERATE

DMF 70491987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE VALERATE USP, BP

DMF 73101988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE VALERATE USP

DMF 226512008

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

Products (1)

#001 — EQ 0.1% BASE

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.