Is there a generic for Malathion?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Malathion, referencing the brand OVIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Malathion?

OVIDE (NDA 018613, TARO) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Malathion?

The Orange Book lists 2 patents against Malathion products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Malathion are approved?

Malathion is approved in the following dosage form: lotion.

FDA Orange Book · active-ingredient family

Malathion

Malathion: 1 brand, 2 generics; first approved Aug 02, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Aug 14, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 14, 2026

9 d ago

Brand (NDA) products

Originator applications

OVIDERLD
TARONDA 0186131982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	LOTION	TOPICAL	Discontinued	—

Generic (ANDA) products (2)

Abbreviated applications

MALATHIONRS
SUVEN PHARMSANDA 0915592012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Rx —
MALATHION
PHARMOBEDIENTANDA 0787432009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% LOTION TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	LOTION	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	LOTION	TOPICAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7977324	Aug 14, 2026	9 d ago	Product
7560445	Feb 01, 2027	in 5 mo	SubstanceProductU-986

Approval history

FDA approval span

First approval

Aug 02, 1982

44 yr 8 mo ago

Most recent approval

May 23, 2012

14 yr 6 mo ago

Approvals span 1982–2012 across 3 FDA applications.

Brand (NDA) 133%

Generic (ANDA) 267%

Malathion: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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