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DECADRON

NDA

DEXAMETHASONE SODIUM PHOSPHATE | N011984 | 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
Citizen Petition from Odin Pharmaceuticals, LLC FDA-2024-P-4158 · 8 docket documents Odin Pharmaceuticals LLC submitted this petition on August 30, 2024 requesting that the FDA determine whether DECADRON (Dexamethasone Sodium Phosphate) Ophthalmic Solution USP, 0.1%, approved under NDA 011984 and held by Merck and Co Inc, was withdrawn for safety or effectiveness reasons pursuant to	505(q)	2024-09-03	Granted	Odin Pharmaceuticals, LLC
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in a 1 mL fill size, using Sicor Pharmaceuticals' reference listed drug formulation as the basis, rath	Other	2008-07-14	Withdrawn	Akorn-Strides, LLC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 Chain9 active DMFs5 inactive

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

EUROAPI FRANCEDEXAMETHASONE SODIUM PHOSPHATE

DMF 39631980

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

DMF 65251986

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDDEXAMETHASONE SODIUM PHOSPHATE

DMF 242152010

CURIA SPAIN SAUDEXAMETHASONE SODIUM PHOSPHATE

DMF 294122015

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE SODIUM PHOSPHATE, BULK API

DMF 348112020

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 362692022

HENAN LIHUA PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 392592024

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 417282025

SYMBIOTEC PHARMALAB PRIVATE LIMITEDDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 424652025

DIOSYNTH BVInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 38411980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 59711985

QUATRUMInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 72251987

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 226472008

TIANJIN TIANYAO PHARMACEUTICALS CO LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 271952013

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

Products (1)

#001 — EQ 0.1% PHOSPHATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC, OTIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.