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NDA

MUPIROCIN | N050591 | GLAXOSMITHKLINE

1 strength0 unique patents0 unique exclusivities

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Teligent, Inc. FDA-2016-P-4274 · 4 docket documents Teligent, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Mupirocin Ointment 2% ANDA 065192, held by Fougera Pharmaceuticals, Inc., as a second reference-listed drug in the Orange Book, because the currently designat	505(q)	2016-12-08	Partially Denied	Teligent, Inc.
Citizen Petition from GlaxoSmithKline FDA-2004-P-0537 · 10 docket documents GlaxoSmithKline filed this citizen petition under 21 CFR 10.30 requesting that the FDA Commissioner refrain from receiving, reviewing, and approving any Abbreviated New Drug Applications (ANDAs) for nasal mupirocin calcium products containing the amorphous form of the active pharmaceutical ingredien	505(q)	2008-05-28	Withdrawn	GlaxoSmithKline

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

Clinical Trials

57 trials from ClinicalTrials.gov, 43 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis NCT00179959	Phase 4	Completed	Northwestern University	31	2005-09 → 2011-03
A Randomized Clinical Trial to Prevent Recurrent CA-MRSA Infection NCT00560599	Phase 3	Completed	loren g miller	350	2007-04 → 2012-12
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections NCT00156377	Phase 4	Completed	University Hospital Muenster	1,200	2002-11
Checklist to Prevent MRSA Surgical Site Infections NCT02216227	N/A	Completed	VA Office of Research and Development	23,005	2014-04-01 → 2021-02-28
Topical Antibiotics in Chronic Rhinosinusitis NCT03673956	Phase 1/2	Completed	Mayo Clinic	19	2018-09-26 → 2021-02-01
Use of Ointments in Prevention of Catheter Related Infections in PD NCT00400595	Phase 4	Completed	University Health Network, Toronto	200	2006-02 → 2010-06
Stop Community MRSA Colonization Among Patients NCT02029872	Phase 4	Completed	Johns Hopkins University	77	2014-01 → 2017-03
Bacterial Decolonization to Prevent Radiation Dermatitis NCT03883828	Phase 2/3	Completed	Montefiore Medical Center	80	2019-06-03 → 2021-12-02
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons NCT00631566	N/A	Completed	Henry M. Jackson Foundation for the Advancement of Military Medicine	550	2007-05 → 2017-10
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers NCT00289588	N/A	Completed	Brooke Army Medical Center	3,000	2005-01 → 2005-12

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

API Supply Chain11 active DMFs2 inactive

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

TAPI NL BVMUPIROCIN

DMF 140401999

TAPI NL BVMUPIROCIN

DMF 152872001

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDMUPIROCIN (NON-STERILE BULK FORM)

DMF 207672007

CONCORD BIOTECH LTDMUPIROCIN USP

DMF 286182014

SYNGEN BIOTECH CO LTDMUPIROCIN

DMF 302922016

KAWMAN PHARMAMUPIROCIN USP

DMF 322682017

FUZHOU CONTAY BIOTECHNOLOGY CO LTDMUPIROCIN

DMF 328242018

BILLS BIOTECH PVT LTDMUPIROCIN IP/BP/USP

DMF 333882018

FUJIAN COMHONY BIOTECHNOLOGY CO LTDMUPIROCIN

DMF 375102022

CHENGDU YACHT BIOTECHNOLOGY CO LTDMUPIROCIN

DMF 424532025

ENDOC BIOTECH PVT LTDMUPIROCIN USP

DMF 425712025

GLAXOSMITHKLINE LLCInactiveMUPIROCIN FREE ACID AND MUPIROCIN CALCIUM (NON-STERILE)

DMF 139611999

XELLIA PHARMACEUTICALS APSInactiveMUPIROCIN USP, NON-STERILE

DMF 238452010

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 10, 2017	SUPPL -34	View Letter (PDF)
Mar 20, 2015	SUPPL -30	View Letter (PDF)
May 27, 2014	SUPPL -32	View Letter (PDF)
Apr 22, 1999	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Dec 31, 1987

No patent or exclusivity listings for this strength.