Viewing data from:

RAPIBLYK

NDA

LANDIOLOL HYDROCHLORIDE | N217202 | AOP HEALTH US LLC

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

10722516

Apr. 25, 2034

NPP

Feb. 13, 2029

NCE

Nov. 22, 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

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

MEHTA APT PVT LTDLANDIOLOL HYDROCHLORIDE

DMF 412362025

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 18, 2026	SUPPL -1	View Letter (PDF)
Nov 26, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 280MG BASE/VIAL

RLD

1 patent2 exclusivities▴

POWDER;INTRAVENOUS | Approved: Nov 22, 2024

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10722516	Apr 25, 2034	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Nov 22, 2029	Active
NPP	Feb 13, 2029	Active