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NIX

NDA

PERMETHRIN | N019435 | 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 Lachman Consultants FDA-2019-P-3232 · 6 docket documents Lachman Consultants filed this petition on behalf of a client requesting that the FDA determine whether NIX (Permethrin) Topical Lotion, NDA 019435, held by GlaxoSmithKline, was voluntarily withdrawn from the commercial market for safety or effectiveness reasons or for commercial considerations. The	505(q)	2019-07-05	Granted	Lachman Consultants
Citizen Petition from Burroughs Wellcome Co. FDA-1990-P-0354 · 4 docket documents Burroughs Wellcome Co. filed this petition on December 19, 1990, requesting three years of marketing exclusivity for NIX (permethrin) Creme Rinse for over-the-counter marketing under its approved NDA, arguing that new clinical studies submitted in support of the OTC application provided essential sa	Other	2017-04-28	Partially Denied	Burroughs Wellcome Co.

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

Clinical Trials

33 trials from ClinicalTrials.gov, 26 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice NCT00244439	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	360	2005-12 → 2006-12
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice NCT00963508	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	403	2009-08 → 2010-03
Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma NCT03813069	Phase 2	Completed	London School of Hygiene and Tropical Medicine	64	2019-01-10 → 2019-12-23
Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice NCT00545753	Phase 3	Completed	ParaPRO LLC	558	2007-09 → 2008-05
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands NCT03236168	Phase 3	Completed	London School of Hygiene and Tropical Medicine	118	2017-08-01 → 2018-02-28
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice NCT00927472	Phase 3	Completed	Sun Pharmaceutical Industries, Inc.	254	2009-08 → 2010-06
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies NCT03973775	Phase 3	Completed	Saptalis Pharmaceuticals LLC	126	2018-04-10 → 2018-12-06
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.NCT02978508	Phase 3	Completed	Mayne Pharma International Pty Ltd	140	2016-11 → 2017-05
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies NCT02572986	Phase 3	Completed	Dr. Reddy's Laboratories Limited	250	2015-09 → 2016-08
Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice NCT00545168	Phase 3	Completed	ParaPRO LLC	480	2007-09 → 2008-05

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

API Supply Chain4 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDPERMETHRIN BPC CIS:TRANS/25:75

DMF 117021995

SRIKEM LABORATORIES PVT LTDPERMETHRIN

DMF 280902014

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPERMETHRIN

DMF 302432016

WAVELENGTH ENTERPRISES LTDPERMETHRIN

DMF 311902016

FMC CORPInactivePERMETHRIN

DMF 121451996

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

Products (1)

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Mar 31, 1986

No patent or exclusivity listings for this strength.