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DECADRON

NDA

DEXAMETHASONE | N012376 | MERCK AND CO INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Acaderm Inc. FDA-2005-P-0394 · 6 docket documents Acaderm Inc. filed this citizen petition under 21 CFR 10.30 and 21 CFR 314.161 requesting that the FDA Commissioner determine whether Aeroseb-Dex (Dexamethasone) Topical Aerosol 0.01% (NDA 083-296) by Allergan Herbert was voluntarily withdrawn from sale for safety or efficacy reasons, as this determ	Other	2011-02-09	Granted	Acaderm Inc.
Citizen Petition from Akorn-Strides, LLC FDA-2007-P-0126 · 6 docket documents Akorn-Strides, LLC filed this citizen petition under section 505(j)(2)(c) seeking FDA approval to file an Abbreviated New Drug Application for Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL in a 1 mL fill size, using Sicor Pharmaceuticals' reference listed drug formulation as the basis, rath	Other	2008-07-14	Withdrawn	Akorn-Strides, LLC

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

Clinical Trials

500 trials from ClinicalTrials.gov, 111 active, 389 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab NCT04302324	Phase 2	Active	Weill Medical College of Cornell University	11	2021-10-28 → 2027-12-28
Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma NCT03030261	Phase 2	Active	Washington University School of Medicine	25	2017-11-22 → 2027-09-26
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma NCT02436707	Phase 2	Active	Canadian Cancer Trials Group	129	2015-10-27 → 2026-12-31
Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM NCT04052880	Phase 2	Active	Larysa Sanchez	17	2019-10-24 → 2026-05
Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma NCT03836014	Phase 3	Active	Assistance Publique - Hôpitaux de Paris	436	2019-07-25 → 2026-07
Trial of Immunomodulatory Therapy in High Risk Solitary Bone Plasmacytoma NCT02544308	Phase 3	Active	University College, London	36	2017-03-10 → 2026-12
A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma NCT02718833	Phase 2	Active	Massachusetts General Hospital	52	2016-06-21 → 2027-12
Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma NCT02253316	Phase 2	Active	Washington University School of Medicine	236	2015-01-20 → 2026-08-31
Hormonal Mechanisms of Sleep Restriction - Axis Study NCT03142893	Phase 1	Active	Peter y. Liu	80	2017-05-08 → 2026-06-30
Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia NCT01424982	Phase 2	Active	M.D. Anderson Cancer Center	88	2011-10-05 → 2027-10-31

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

API Supply Chain11 active DMFs19 inactive

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

EUROAPI FRANCEDEXAMETHASONE

DMF 17481971

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE USP MICRONIZED

DMF 45241982

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE, USP

DMF 171412004

MAHIMA LIFE SCIENCES PRIVATE LTDDEXAMETHASONE USP

DMF 278882013

FARMABIOS SPADEXAMETHASONE USP

DMF 315322017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE BULK API

DMF 348102020

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 362702022

SHANDONG SIRUI PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 368942022

SYMBIOTEC PHARMALAB PRIVATE LTDDEXAMETHASONE USP

DMF 381622023

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 409942024

FARMABIOS SPADEXAMETHASONE MICRONIZED STERILE

DMF 435092026

ORGANON INCInactiveDEXAMETHASONE

DMF 5191963

ORGANON INCInactiveDEXAMETHASONE

DMF 5421963

ORGANON INCInactiveDEXAMETHASONE 21-PHOSPHATE

DMF 5821963

SF DURST AND CO INCInactiveDEXAMETHASONE

DMF 10951967

ORGANON INCInactiveDEXAMETHASONE 21-TERTIARY BUTYLACETATE

DMF 13431969

ANTIBIOTICOS SPAInactiveDEXAMETHASONE, NON-STERILE (BULK)

DMF 22051973

ANTIBIOTICOS SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE BULK

DMF 23781974

ROUSSEL CORPInactiveDEXAMETHASONE SODIUM METASULFOBENZOATE

DMF 27371976

ORGANON INCInactiveDEXAMETHASONE

DMF 28161976

BLASCHIM SPAInactiveDEXAMETHASONE 21 SODIUM PHOSPHATE

DMF 28491977

ANTIBIOTICOS SPAInactiveDEXAMETHASONE 21-SODIUM M-SULFOBENZOATE

DMF 36841980

BLASCHIM SPAInactiveDEXAMETHASONE

DMF 36861980

CYCLO PRODUCTS INCInactiveDEXAMETHASONE

DMF 37331980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE BASE, USP XX

DMF 42851981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE SODIUM PHOSPHATE USP XX

DMF 44971982

DIOSYNTH BVInactiveDEXAMETHASONE MICRO AND NON-MICRO

DMF 49371983

DIOSYNTH BVInactiveDEXAMETHASONE ACETATE MICRO AND NON MICRO

DMF 49441983

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE

DMF 60301985

QUATRUMInactiveDEXAMETHASONE BASE BP/KUSP AS

DMF 62331986

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

Products (1)

#002 — 0.5MG/5ML

0 patents0 exclusivities▴

ELIXIR;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.