Viewing data from:

VYZULTA

NDA

LATANOPROSTENE BUNOD | N207795 | BAUSCH AND LOMB INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

8058467

Feb. 21, 2029

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
BAUSCH & LOMB INCORPORATED et al v. SABA ILAC SANAYI VE TICARET A.S. 2:2025cv15127 1 patentANDA 218547latanoprostene bunod	D.N.J.	2025-08-29	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy of Latanoprostene Bunod in Lowering Intraocular Pressure in Japanese Healthy Male Volunteers NCT01895985	Phase 1	Completed	Bausch & Lomb Incorporated	24	2013-07 → 2013-10
Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension NCT01223378	Phase 2	Completed	Bausch & Lomb Incorporated	413	2010-12-13 → 2012-06-22
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT NCT01895972	Phase 3	Completed	Bausch & Lomb Incorporated	130	2013-07-05 → 2015-04-14
Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity NCT03931317	N/A	Completed	University of California, San Diego	70	2018-12-03 → 2023-03-01
A Study to Evaluate the Effect of Latanoprostene Bunod Ophthalmic Solution 0.024% on Episcleral Venous Pressure and Outflow Facility in Participants With Ocular Hypertension NCT04140279	Phase 4	Withdrawn	Bausch & Lomb Incorporated	—	2022-05-13 → 2023-08

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

$102.26

per ml

Lowest NADAC/Unit

$102.24

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208050402VYZULTA 0.024% OPHTH SOLUTION	$102.26	ML	Brand	—	2026-06-17
24208050405VYZULTA 0.024% OPHTH SOLUTION	$102.24	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

$151.11

Highest Price

$287.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24208-0504-02VYZULTA 0.024% SOLN,OPH	$151.11	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0504-02VYZULTA 0.024% SOLN,OPH	$151.11	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0504-05VYZULTA 0.024% SOLN,OPH	$287.47	FSS	Bausch & Lomb Americas Inc.	09/14/2027
24208-0504-05VYZULTA 0.024% SOLN,OPH	$287.47	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 Vyzulta (2024)

Total Spending

$128.3M

Total Claims

292,207

Beneficiaries

75,825

Avg Cost/Unit

$98.84

Spending Trend

$24.5M(2019)→$37.6M(2020)→$57.6M(2021)→$86.5M(2022)→$117.4M(2023)→$128.3M(2024)

YoY Change:-2.0%

5yr CAGR:+5.0%

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

API Supply Chain6 active DMFs

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

MSN LABORATORIES PRIVATE LTDLATANOPROSTENE BUNOD

DMF 340332019

CAYMAN PHARMA SROLATANOPROSTENE BUNOD

DMF 374292023

CHIROGATE INTERNATIONAL INCLATANOPROSTENE BUNOD

DMF 379762023

EVERLIGHT CHEMICAL INDUSTRIAL CORPLATANOPROSTENE BUNOD

DMF 391532023

YS LIFE SCIENCE CO LTDLATANOPROSTENE BUNOD

DMF 404782024

NEWCHEM SPALATANOPROSTENE BUNOD

DMF 427912025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2018	SUPPL -2	View Letter (PDF)
Nov 20, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.024%

RLDAB

1 patent0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Nov 2, 2017

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8058467	Feb 21, 2029	—	Yes	—		—