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

2 mo ago

Brand (NDA) products

Originator applications

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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

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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

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7977324	Aug 14, 2026	2 mo ago	Product
7560445	Feb 01, 2027	in 3 mo	SubstanceProductU-986

Approval history

FDA approval span

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First approval

Aug 02, 1982

44 yr 10 mo ago

Most recent approval

May 23, 2012

14 yr 8 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.

Related FDA reference tools

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