Petition	Type	Filed	Status	Petitioner
Aerscher LLC - Citizen Petition FDA-2009-P-0459 · 4 docket documents Aerscher LLC filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to submit an ANDA for buprenorphine hydrochloride 8mg combined with naloxone hydrochloride 2mg in an orally soluble strip format marketed as Buprox, which differs fr	Other	2009-10-22	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

174 trials from ClinicalTrials.gov — 1 recruiting, 131 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder NCT04375033	Phase 4	Recruiting	VA Office of Research and Development	952	2020-11-03 → 2029-05-31
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function NCT01367561	Phase 1	Completed	Bausch Health Americas, Inc.	15	2002-10 → 2003-05
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients NCT00879996	Phase 4	Completed	State University of New York at Buffalo	54	2009-04 → 2011-10
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.NCT01596764	Phase 1	Completed	University Medicine Greifswald	16	2011-05 → 2012-01
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray NCT03223896	Phase 2	Completed	Finnish Institute for Health and Welfare	20	2017-02-14 → 2017-06-30
Effect of High-dose Naloxone Following Third Molar Extraction NCT02976337	Phase 2	Completed	mads u werner	23	2017-10-12 → 2023-12-27
A Pilot Study of the Bioavailability of Nasal Naloxone NCT01939444	Phase 2	Completed	Norwegian University of Science and Technology	5	2013-08 → 2014-11
PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain NCT01719757	Phase 4	Completed	Mundipharma Korea Ltd	359	2012-07 → 2014-04
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder NCT02669901	N/A	Completed	University of New Mexico	395	2016-04-04 → 2020-08-20
A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain NCT00513656	Phase 2	Completed	Mundipharma Research GmbH & Co KG	230	2007-09 → 2010-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 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

NORAMCO LLCNALOXONE HYDROCHLORIDE (PROCESS II)

DMF 430512026

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
Apr 3, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG/0.4ML (0.4MG/0.4ML)

RLD

21 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Approved: Apr 3, 2014

Patents (21) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7731686	Jun 10, 2026	—	—	Yes	—	—
7749194	Oct 30, 2028	—	—	Yes	—	—
7947017	Mar 12, 2028	—	—	Yes	—	—
8021344	Nov 2, 2029	—	—	Yes	—	—
8206360	Feb 27, 2027	—	—	Yes	—	—
8226610	Apr 10, 2029	—	—	Yes	—	—
8231573	Nov 25, 2028	—	—	Yes	—	—
8627816	Feb 4, 2032	—	—	Yes	—	—
8926594	Mar 31, 2026	—	—	Yes	—	—
8939943	Feb 28, 2031	—	—	Yes	—	—
9022022	Feb 28, 2031	—	—	Yes	—	—
9238108	Feb 20, 2027	—	—	Yes	—	—
9278182	Feb 1, 2026	—	—	Yes	—	—
9474869	Feb 28, 2031	—	—	Yes		—
9517307	Jul 18, 2034	—	—	Yes		—
9724471	May 23, 2027	—	—	Yes		—
10143972	May 24, 2031	—	—	—		—
10220158	Mar 20, 2035	—	—	Yes		—
10322239	Feb 28, 2031	—	—	—		—
10960155	Jun 25, 2026	—	—	Yes	—	—
11590286	Dec 12, 2026	—	—	Yes	—	—