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NDA

NALOXONE HYDROCHLORIDE | N217722 | HARM REDUCTION THERAPEUTICS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

Today

11020343

May. 11, 2032

11806428

May. 11, 2032

12458591

May. 11, 2032

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 Chain8 active DMFs2 inactive

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

ASPEN OSS BVNALOXONE HYDROCHLORIDE

DMF 140341999

MACFARLAN SMITH LTDNALOXONE HYDROCHLORIDE

DMF 207452007

FRANCOPIA A EUROAPI CONALOXONE HYDROCHLORIDE

DMF 231422009

SUN PHARMACEUTICAL INDUSTRIES LTDNALOXONE HYDROCHLORIDE DIHYDRATE USP

DMF 233892010

NORAMCO LLCNALOXONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 246332011

SIEGFRIED LTDNALOXONE HYDROCHLORIDE DIHYDRATE

DMF 246682011

SUN PHARMACEUTICAL INDUSTRIES LTDNALOXONE HYDROCHLORIDE DIHYDRATE USP (PROCESS II)

DMF 364322021

SICHUAN QINGMU PHARMACEUTICAL CO LTDNALOXONE

DMF 422332025

DIOSYNTH BVInactiveNALOXONE HYDROCHLORIDE

DMF 45951982

EXTAL PTY LTD DIV JOHNSON AND JOHNSONInactiveNALOXONE HYDROCHLORIDE

DMF 71381987

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 28, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG/SPRAY

RLD

3 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jul 28, 2023

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11020343	May 11, 2032	—	—	—		—
11806428	May 11, 2032	—	—	Yes	—	—
12458591	May 11, 2032	—	—	—		—