Is there a generic for Ingenol mebutate?

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

What is the reference-listed drug for Ingenol mebutate?

PICATO (NDA 202833, LEO LABS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ingenol mebutate?

The Orange Book lists 12 patents against Ingenol mebutate 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 Ingenol mebutate are approved?

Ingenol mebutate is approved in the following dosage form: gel.

FDA Orange Book · active-ingredient family

Ingenol mebutate

Ingenol mebutate: 1 brand, 2 generics; first approved Jan 23, 2012; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 2 ANDA applications approved.

Earliest patent expiry Dec 18, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 18, 2026

in 2 mo

Brand (NDA) products

Originator applications

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PICATORLD
LEO LABSNDA 20283320122 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.015% GEL TOPICAL Discontinued -
0.05% GEL TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.015%	GEL	TOPICAL	Discontinued	-
0.05%	GEL	TOPICAL	Discontinued	-

Generic (ANDA) products (2)

Abbreviated applications

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INGENOL MEBUTATE
PADAGIS ISRAELANDA 2090192019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05% GEL TOPICAL Discontinued -
INGENOL MEBUTATE
PADAGIS ISRAELANDA 2090182019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.015% GEL TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.015%	GEL	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
8716271	Dec 18, 2026	in 2 mo	U-1440
8536163	Dec 18, 2026	in 2 mo	U-1440
8735375	Dec 18, 2026	in 2 mo	U-1440
9820959	Dec 18, 2026	in 2 mo	ProductU-1440
9861603	Dec 18, 2026	in 2 mo	U-1440
8377919	Dec 18, 2026	in 2 mo	Product
8372827	Dec 18, 2026	in 2 mo	Product
9833429	Dec 18, 2026	in 2 mo	Product
8372828	Dec 18, 2026	in 2 mo	Product
9833428	Dec 18, 2026	in 2 mo	Product
8278292	Jul 06, 2027	in 9 mo	Product
9789078	May 15, 2033	in 6 yr 8 mo	U-2138

Approval history

FDA approval span

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First approval

Jan 23, 2012

15 yr ago

Most recent approval

Jan 09, 2019

7 yr 11 mo ago

Approvals span 2012–2019 across 3 FDA applications.

Brand (NDA) 133%

Generic (ANDA) 267%

Ingenol mebutate: 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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