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NDA

MUPIROCIN CALCIUM | N050746 | 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

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Encube Ethicals Private Limited FDA-2018-P-1516 · 3 docket documents Encube Ethicals Private Limited filed this citizen petition on April 13, 2018, requesting that the FDA designate ANDA 201587 held by Glenmark Pharmaceuticals Inc USA as a reference standard for Mupirocin Calcium Cream, EQ 2% Base, because the currently designated reference listed drug and reference	505(q)	2018-04-16	Open	Encube Ethicals Private Limited
Citizen Petition from Prinston Pharmaceutical Inc. FDA-2018-P-0829 · 3 docket documents Prinston Pharmaceutical Inc. filed this citizen petition pursuant to 21 C.F.R. §§ 10.25(a) and 10.30 requesting that the FDA designate ANDA 201587 held by Glenmark Pharmaceuticals Inc USA as a Reference Standard for Mupirocin Calcium Cream, EQ 2% Base, to replace the current reference standard NDA 0	505(q)	2018-02-22	Granted	Prinston Pharmaceutical Inc.
Citizen Petition from Goodwin Procter LLP FDA-2017-P-6108 · 3 docket documents Goodwin Procter LLP filed this citizen petition requesting that FDA amend the Orange Book to designate ANDA 201587 as a Reference Standard for mupirocin calcium cream, 2% Base. The petition argues that the current reference listed drug, Bactroban (NDA 050746), has been unavailable since a July 2016	505(q)	2017-10-12	Granted	Goodwin Procter LLP
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nasal mupirocin calcium products containing the amorphous form of the active pharmaceutical ingredien	505(q)	2008-05-28	Withdrawn	GlaxoSmithKline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 Chain7 active DMFs2 inactive

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

TAPI NL BVMUPIROCIN CALCIUM

DMF 200412006

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDMUPIROCIN CALCIUM

DMF 247162011

CONCORD BIOTECH LTDMUPIROCIN CALCIUM USP

DMF 289072015

FUZHOU CONTAY BIOTECHNOLOGY CO LTDMUPIROCIN CALCIUM

DMF 328322018

KAWMAN PHARMAMUPIROCIN CALCIUM USP

DMF 339082019

FUJIAN COMHONY BIOTECHNOLOGY CO LTDMUPIROCIN CALCIUM

DMF 375092022

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)MUPIROCIN CALCIUM

DMF 422352025

CHEMAGIS LTDInactiveMUPIROCIN CALCIUM (AMORPHOUS)

DMF 165412003

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMUPIROCIN CALCIUM DIHYDRATE

DMF 229132009

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 20, 2020	SUPPL -22	View Letter (PDF)
May 10, 2017	SUPPL -21	View Letter (PDF)
Dec 15, 2015	SUPPL -20	View Letter (PDF)
Mar 20, 2015	SUPPL -13	View Letter (PDF)
May 27, 2014	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 11, 1997

No patent or exclusivity listings for this strength.