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NDA

DEXAMETHASONE SODIUM PHOSPHATE | N011977 | 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov — 8 recruiting, 2 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma NCT04933539	Phase 2	Active	National Cancer Institute (NCI)	14	2022-10-31 → 2032-10-31
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT NCT04858776	Phase 2	Active	Mercator MedSystems, Inc.	60	2022-08-08 → 2027-05-31
Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain NCT07665762	Phase 3	Not Yet Recruiting	The University of Hong Kong	90	2026-06-15 → 2029-03-01
Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma NCT07614360	Phase 2	Not Yet Recruiting	GlaxoSmithKline	150	2026-08-03 → 2031-02-11
Laser vs Lontophoresis in KOA NCT07666061	N/A	Not Yet Recruiting	Kafrelsheikh University	66	2026-08-01 → 2027-04-01
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)NCT07318558	Phase 3	Recruiting	Merck Sharp & Dohme LLC	900	2026-02-16 → 2033-02-25
Using a Steroid Mouthwash to Prevent Mouth Sores During Chemotherapy NCT07287826	Phase 4	Recruiting	Woman's	45	2026-04-02 → 2028-01
Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma NCT06232044	Phase 1/2	Recruiting	Alliance for Clinical Trials in Oncology	88	2025-04-23 → 2030-08-01
Local Dexamethasone Administration in Symptomatic Irreversible Pulpitis NCT07672873	N/A	Recruiting	Marmara University	84	2026-06-15 → 2026-12-18
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma NCT07284758	Phase 2	Recruiting	C4 Therapeutics, Inc.	100	2026-02-18 → 2030-03

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

Medicare Part D Spending

CMS annual spending data for Dexamethasone Sodium Phosphate* (2023)

Total Spending

$3.7M

Total Claims

95,809

Beneficiaries

57,302

Avg Cost/Unit

$5.87

Spending Trend

$5.0M(2019)→$3.7M(2020)→$3.3M(2021)→$3.5M(2022)→$3.7M(2023)

YoY Change:+3.6%

5yr CAGR:-4.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs5 inactive

8 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

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 0.05% PHOSPHATE

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.