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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vyzulta (2023)

Total Spending

$117.4M

Total Claims

261,217

Beneficiaries

69,308

Avg Cost/Unit

$100.85

Spending Trend

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

YoY Change:+7.3%

5yr CAGR:+7.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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