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ZYLET

NDA

LOTEPREDNOL ETABONATE; TOBRAMYCIN | N050804 | BAUSCH AND LOMB 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

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis NCT03464435	Phase 4	Completed	Zhongshan Ophthalmic Center, Sun Yat-sen University	20	2016-11-01 → 2018-02-01
Pediatric Zylet Safety and Efficacy Study NCT00420628	Phase 4	Completed	Bausch & Lomb Incorporated	108	2006-11 → 2009-06
Zylet vs TobraDex in Blepharokeratoconjunctivitis NCT00447577	Phase 4	Completed	Bausch & Lomb Incorporated	276	2007-01 → 2007-06
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis NCT00705159	Phase 4	Completed	Bausch & Lomb Incorporated	137	2008-06 → 2010-05
Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex NCT00532961	Phase 4	Completed	Bausch & Lomb Incorporated	310	2005-02 → 2005-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$64.53

per ml

Lowest NADAC/Unit

$64.45

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208035805ZYLET EYE DROPS	$64.53	ML	Brand	—	2026-06-17
24208035810ZYLET EYE DROPS	$64.45	ML	Brand	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$226.66

Highest Price

$453.38

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24208-0358-05ZYLET OPHTH SUSPENSION	$226.66	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0358-05ZYLET OPHTH SUSPENSION	$226.66	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0358-10ZYLET OPHTH SUSPENSION	$453.38	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0358-10ZYLET OPHTH SUSPENSION	$453.38	Big4	Bausch & Lomb Americas Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Zylet (2024)

Total Spending

$3.1M

Total Claims

8,050

Beneficiaries

5,598

Avg Cost/Unit

$63.61

Spending Trend

$4.3M(2019)→$3.4M(2020)→$3.5M(2021)→$3.8M(2022)→$3.8M(2023)→$3.1M(2024)

YoY Change:-3.5%

5yr CAGR:+4.5%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 26, 2021	SUPPL -26	View Letter (PDF)
Feb 8, 2013	SUPPL -18	View Letter (PDF)
Oct 4, 2012	SUPPL -17	View Letter (PDF)
Jun 8, 2010	SUPPL -15	View Letter (PDF)
Dec 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%;0.3%

RLDAB

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Dec 14, 2004

No patent or exclusivity listings for this strength.