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MAXIDEX

NDA

DEXAMETHASONE | N013422 | HARROW EYE LLC

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

500 trials from ClinicalTrials.gov, 147 active, 353 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis NCT04847453	Phase 1	Active	National Cancer Institute (NCI)	24	2022-08-03 → 2028-06-30
Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy NCT00871013	Phase 2	Active	University of Arkansas	160	2009-03 → 2027-12
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma NCT04442022	Phase 2/3	Active	Karyopharm Therapeutics Inc	501	2020-09-03 → 2026-12
Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer NCT02491632	Phase 2/3	Active	M.D. Anderson Cancer Center	90	2015-08-13 → 2026-12-31
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma NCT00098475	Phase 3	Active	National Cancer Institute (NCI)	452	2004-11-03 → 2026-10-23
Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma NCT03756896	Phase 2	Active	Emory University	29	2019-01-25 → 2026-06-30
A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant NCT04096066	Phase 3	Active	Fondazione EMN Italy Onlus	84	2019-07-01 → 2026-01-01
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
A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance NCT03114865	Phase 1/2	Active	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	44	2017-09-05 → 2026-10-30
Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma NCT03763162	Phase 2	Active	M.D. Anderson Cancer Center	40	2019-01-17 → 2027-10-30

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 1 NDC

Highest NADAC/Unit

$13.20

per ml

Lowest NADAC/Unit

$13.20

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667060005MAXIDEX 0.1% EYE DROPS	$13.20	ML	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$52.32

Highest Price

$52.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0600-05MAXIDEX 0.1% SUSP,OPH	$52.32	FSS	Harrow Eye, LLC	03/14/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Maxidex (2024)

Total Spending

$99K

Total Claims

1,040

Beneficiaries

657

Avg Cost/Unit

$16.75

Spending Trend

$146K(2019)→$100K(2020)→$89K(2021)→$13K(2022)→$100K(2023)→$99K(2024)

YoY Change:-6.4%

5yr CAGR:+1.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 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

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

BLASCHIM SPAInactiveDEXAMETHASONE

DMF 36861980

ANTIBIOTICOS SPAInactiveDEXAMETHASONE 21-SODIUM M-SULFOBENZOATE

DMF 36841980

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.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2021	SUPPL -49	View Letter (PDF)
May 17, 2021	SUPPL -46	View Letter (PDF)
Nov 9, 2017	SUPPL -45	View Letter (PDF)
May 29, 2003	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.