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MALATHION | N018613 | TARO PHARMACEUTICAL INDUSTRIES LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (2)Today

2027

Today

7560445

Feb. 1, 2027

7977324

Aug. 14, 2026

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Taro Pharmaceutical Industries Ltd. et al v. Encube Ethicals Pvt. Ltd. 1:2021cv01614	D. Del.	2021-11-15	Terminated 2023-05-17	—
TARO PHARMACEUTICAL INDUSTRIES LTD. et al v. NOVITIUM PHARMA, LLC 3:2019cv01028 2 patentsANDA 212255malathion	D.N.J.	2019-01-24	Terminated 2020-06-29	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Ivermectin in the Treatment of Head Lice NCT00819520	Phase 3	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	812	2004-02 → 2004-10
Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice NCT00927407	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	24	2009-07 → 2009-08
Pediatric Head Lice Study Product Comparison NCT02213055	Phase 2	Completed	Hackensack Meridian Health	97	2009-05 → 2014-08
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
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice NCT00752973	Phase 2/3	Completed	Sun Pharmaceutical Industries, Inc.	12	2008-09 → 2012-01

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

Medicare Part D Spending

CMS annual spending data for Malathion (2024)

Total Spending

$352K

Total Claims

1,742

Beneficiaries

1,185

Avg Cost/Unit

$2.92

Spending Trend

$675K(2019)→$538K(2020)→$478K(2021)→$380K(2022)→$447K(2023)→$352K(2024)

YoY Change:-12.4%

5yr CAGR:-3.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs1 inactive

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

TOPCHEM PHARMACEUTICALS LTDMALATHION

DMF 210452008

TARO PHARMACEUTICAL INDUSTRIES LTDMALATHION USP

DMF 233662010

AREVA SYNTHETICS LLCMALATHION USP

DMF 345042020

CML EUROPE BVInactiveMALATHION USP

DMF 238972010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 14, 2011	SUPPL -17	View Letter (PDF)
Apr 16, 2003	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

2 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Aug 2, 1982

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7560445	Feb 1, 2027	—	Yes	Yes		—
7977324	Aug 14, 2026	—	—	Yes	—	—