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NATACYN

NDA

NATAMYCIN | N050514 | 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Bongards Creameries FDA-2023-P-2178 · 10 docket documents Bongards Creameries submitted this citizen petition on May 18, 2023, requesting that the Food and Drug Administration amend 21 CFR 133.169 to allow the use of Natamycin as a mold inhibitor in Pasteurized Process Cheese slices, in addition to currently approved preservatives such as sorbic and propio	Other	2023-05-30	Open	Bongards Creameries

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

Clinical Trials

6 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mycotic Ulcer Treatment Trial I NCT00996736	Phase 3	Completed	University of California, San Francisco	323	2010-04 → 2012-07
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers NCT02731638	Phase 3	Completed	University of California, San Francisco	70	2016-09 → 2018-07
Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer NCT00557362	Phase 1/2	Completed	University of California, San Francisco	120	2007-11 → 2008-08
A Clinical Trial of the Treatment of Fungal Corneal Ulcers With Povidone-Iodine NCT00516399	Phase 3	Terminated	University of California, Los Angeles	78	2008-03 → 2010-12
Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis NCT02328053	N/A	UNKNOWN	Aravind Eye Care System	20	2014-02 → 2015-09
Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis NCT03230058	Phase 2/3	UNKNOWN	L.V. Prasad Eye Institute	55	2017-01-01 → 2018-09-30

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

VA Federal Supply Schedule

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

Lowest Price

$38.55

Highest Price

$38.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0012-05NATACYN 5% SUSP, OPH	$38.55	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 Natacyn (2024)

Total Spending

$970K

Total Claims

1,282

Beneficiaries

788

Avg Cost/Unit

$49.88

Spending Trend

$74K(2021)→$648K(2022)→$767K(2023)→$970K(2024)

YoY Change:+50.4%

5yr CAGR:+15.2%

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

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHANDONG FREDA BIOTECHNOLOGY CO LTDNATAMYCIN

DMF 420632025

GIST-BROCADES NV PHARMACEUTICALSInactiveNATAMYCIN

DMF 135121998

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 18, 2025	SUPPL -22	View Letter (PDF)
Jul 23, 2008	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.