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NDA

OZENOXACIN | N208945 | LNHC INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

Today

Jan. 29, 2032

Dec. 15, 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 Chain3 active DMFs

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

INTERQUIM SAOZENOXACIN

DMF 250232011

MAITHRI DRUGS PRIVATE LTDOZENOXACIN

DMF 348982020

METROCHEM API PRIVATE LTDOZENOXACIN

DMF 354872020

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 13, 2019	SUPPL -1	View Letter (PDF)
Dec 11, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

2 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 11, 2017

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9180200	Jan 29, 2032	—	—	Yes		—
9399014	Dec 15, 2029	—	—	—		—