Assyro AI

FDA Orange Book · active-ingredient family

Ingenol mebutate

Ingenol mebutate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PICATO · NDA 202833

1

Brand (NDA)

2

Generics (ANDA)

12

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel

ProductApplicantApplicationTEApproved
PICATORLD×2LEO LABSNDA 202833—Jan 23, 2012

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
INGENOL MEBUTATEPADAGIS ISRAELANDA 209019—Jan 09, 2019
INGENOL MEBUTATEPADAGIS ISRAELANDA 209018—Jan 07, 2019

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8716271Dec 18, 2026in 6 mo
U-1440
8536163Dec 18, 2026in 6 mo
U-1440
8735375Dec 18, 2026in 6 mo
U-1440
9820959Dec 18, 2026in 6 mo
ProductU-1440
9861603Dec 18, 2026in 6 mo
U-1440
8377919Dec 18, 2026in 6 mo
Product
8372827Dec 18, 2026in 6 mo
Product
9833429Dec 18, 2026in 6 mo
Product
8372828Dec 18, 2026in 6 mo
Product
9833428Dec 18, 2026in 6 mo
Product
8278292Jul 06, 2027in 1 yr 1 mo
Product
9789078May 15, 2033in 7 yr
U-2138

Ingenol mebutate — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo