Ingenol Mebutate Patent Expiration

Ingenol Mebutate is Used for treating actinic keratosis by inhibiting proliferative activity of neoplastic cells and stimulating the immune system. It was first introduced by Leo Laboratories Ltd in its drug Picato on Jan 23, 2012. 2 different companies have introduced drugs containing Ingenol Mebutate.


Ingenol Mebutate Patents

Given below is the list of patents protecting Ingenol Mebutate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Picato US6432452 Anti-cancer compounds Aug 19, 2018

(Expired)

Leo Labs
Picato US6787161 Anti-cancer compounds Aug 19, 2018

(Expired)

Leo Labs
Picato US6844013 Methods of stimulating the immune system Dec 13, 2018

(Expired)

Leo Labs
Picato US7410656 Anti-cancer compounds Aug 19, 2018

(Expired)

Leo Labs
Picato US8278292 Therapeutic compositions Jul 06, 2027 Leo Labs
Picato US8372827 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US8372828 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US8377919 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US8536163 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US8716271 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US8735375 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US9789078 Method of topically treating actinic keratosis with ingenol mebutate cycle therapy May 15, 2033 Leo Labs
Picato US9820959 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US9833428 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US9833429 Therapeutic compositions Dec 18, 2026 Leo Labs
Picato US9861603 Therapeutic compositions Dec 18, 2026 Leo Labs


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Ingenol Mebutate Generics

Several generic applications have been filed for Ingenol Mebutate.

Given below is the list of companies who have filed for Ingenol Mebutate generic.


1. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ingenol Mebutate. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.015% gel Discontinued TOPICAL N/A Jan 7, 2019
0.05% gel Discontinued TOPICAL N/A Jan 9, 2019