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NALOXONE HYDROCHLORIDE

ANDA

NALOXONE HYDROCHLORIDE | A211951 | PADAGIS ISRAEL PHARMACEUTICALS LTD

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ADAPT PHARMA OPERATIONS LIMITED et al v. PERRIGO UK FINCO LIMITED PARTNERSHIP 2:2018cv16987 1 patentANDA 211951naloxone hydrochloride	D.N.J.	2018-12-07	Terminated 2019-05-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 25, 2023	SUPPL -3	View Letter (PDF)
Jan 7, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jun 21, 2022

No patent or exclusivity listings for this strength.