Viewing data from:

KOVANAZE

NDA

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE | N208032 | ST RENATUS LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

Today

Apr. 2, 2030

Apr. 2, 2030

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 9, 2018	SUPPL -4	View Letter (PDF)
Jul 11, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1MG/SPRAY;6MG/SPRAY

RLD

2 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jun 29, 2016

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8580282	Apr 2, 2030	—	—	Yes		—
9308191	Apr 2, 2030	—	—	Yes		—