Viewing data from:

VIGAMOX

NDA

MOXIFLOXACIN HYDROCHLORIDE | N021598 | 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Alcon Pharmaceuticals Ltd. et al v. Akorn, Inc. 1:2015cv00948 2 patentsANDA 021598moxifloxacin hydrochloride	D. Del.	2015-10-21	Terminated 2015-11-13	—
Alcon Pharmaceuticals Ltd et al v. Apotex Inc. et al 1:2012cv00960 2 patentsANDA 90080moxifloxacin hydrochloride	D. Del.	2012-07-20	Terminated 2013-12-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from RegCon Solutions, LLC FDA-2023-P-4337 · 7 docket documents RegCon Solutions, LLC filed this suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Moxifloxacin hydrochloride ophthalmic solution 0.5% in unit-dose form (0.4 mL fill volume) suitable for submission as an ANDA, with the reference lis	Suitability	2023-10-04	Denied	RegCon Solutions, LLC
Suitability Petition from Regcon Solutions FDA-2022-P-3046 · 6 docket documents Regcon Solutions submitted a suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Moxifloxacin hydrochloride ophthalmic solution 0.5% in unit-dose format (0.4 mL fill volume) suitable for submission as an abbreviated new drug applicati	Suitability	2022-12-01	Withdrawn	Regcon Solutions

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

Clinical Trials

347 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 296 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery NCT03244072	Phase 2/3	Not Yet Recruiting	Jason Ahee, M.D.	60,000	2026-06-01 → 2031-10
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment NCT04310930	Phase 2/3	Recruiting	The University of Queensland	300	2020-03-02 → 2030-06-30
The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection NCT02373280	N/A	Recruiting	Seoul National University Bundang Hospital	600	2014-08 → 2027-12
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery NCT04205916	Phase 4	Recruiting	Ophthalmic Consultants of Long Island	50	2019-11-04 → 2020-12-01
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers NCT02910635	Phase 1	Completed	Ionis Pharmaceuticals, Inc.	52	2016-09-19 → 2016-12-20
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval NCT01525394	Phase 1	Completed	Eisai Inc.	52	2010-12
Shortening Treatment by Advancing Novel Drugs NCT02342886	Phase 3	Completed	Global Alliance for TB Drug Development	284	2015-02 → 2018-05
Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis NCT02595359	Phase 2	Completed	Universidade Federal de Pernambuco	1,000	2013-01 → 2018-06-20

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$31.81

per ml

Lowest NADAC/Unit

$1.64

per ml

Brand NDCs

Generic NDCs

Avg Brand: $31.81

Avg Generic: $1.64

95% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667070003VIGAMOX 0.5% EYE DROPS	$31.81	ML	Brand	$1.64	2026-06-17
00781713593MOXIFLOXACIN 0.5% EYE DROPS	$1.64	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$6.11

Highest Price

$83.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0700-03VIGAMOX) 0.5% SOLN,OPH	$83.27	FSS	Harrow Eye, LLC	03/14/2029
00781-7135-93MOXIFLOXACIN HCL 0.5% SOLN,OPH	$6.11	FSS	Sandoz, Inc.	08/14/2028

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

Medicare Part D Spending

CMS annual spending data for Vigamox (2024)

Total Spending

$119K

Total Claims

489

Beneficiaries

227

Avg Cost/Unit

$60.70

Spending Trend

$13K(2021)→$186K(2022)→$167K(2023)→$119K(2024)

YoY Change:-7.6%

5yr CAGR:+4.0%

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

API Supply Chain20 active DMFs5 inactive

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

DR REDDYS LABORATORIES LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 169992003

NEULAND LABORATORIES LTDMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP

DMF 187892005

MSN PHARMACHEM PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (MONOHYDRATE) [ROUTE CODE - "MM"]

DMF 207552007

OLON SPAMOXIFLOXACIN HYDROCHLORIDE

DMF 237452010

MSN PHARMACHEM PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (ANHYDROUS) [ROUTE CODE: "MP"]

DMF 240032010

APITORIA PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

DMF 243712010

UNIMARK REMEDIES LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 253622011

SHARON BIO MEDICINE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 259302012

HETERO DRUGS LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 260742012

HETERO DRUGS LTDMOXIFLOXACIN HYDROCHLORIDE ANHYDROUS

DMF 265252012

HEC PHARM CO LTDMOXIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 273942013

MACLEODS PHARMACEUTICALS LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 293732015

CHROMO LABORATORIES INDIA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 317202019

INNOVARE LABS PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 352712020

REYOUNG CORPORATIONMOXIFLOXACIN HYDROCHLORIDE

DMF 355572021

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 381152023

ZHEJIANG SHAXING TECHNOLOGY CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 390202023

NEWLAND PHARMACEUTICAL CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 418082025

SHANKUS PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE EP BP

DMF 425332025

SHANKUS PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 425362025

MYLAN LABORATORIES LTDInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 170002003

CIPLA LTDInactiveMOXIFLOXACIN HYDROCHLORIDE PH. EUR.

DMF 201702008

ITF CHEMICAL LTDAInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 233152009

ALP PHARM BEIJING CO LTDInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 253682011

HISUN PHARMACEUTICAL NANTONG CO LTDInactiveMOXIFLOXACIN HYDROCHLORIDE USP

DMF 285972014

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jun 3, 2020	SUPPL -24	View Letter (PDF)
May 13, 2020	SUPPL -23	View Letter (PDF)
Mar 20, 2017	SUPPL -22	View Letter (PDF)
Oct 12, 2011	SUPPL -17	View Letter (PDF)
Jul 1, 2004	SUPPL -8	View Letter (PDF)
Apr 20, 2004	SUPPL -2	View Letter (PDF)
Oct 3, 2003	SUPPL -5	View Letter (PDF)
Oct 3, 2003	SUPPL -1	View Letter (PDF)
May 29, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

RLDAT1

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 15, 2003

No patent or exclusivity listings for this strength.