➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Medtronic
Colorcon
AstraZeneca
Boehringer Ingelheim

Last Updated: July 28, 2021

DrugPatentWatch Database Preview

INGENOL MEBUTATE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for ingenol mebutate and what is the scope of patent protection?

Ingenol mebutate is the generic ingredient in two branded drugs marketed by Perrigo Uk Finco and Leo Labs, and is included in three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ingenol mebutate has thirty-five patent family members in twenty-one countries.

There are three drug master file entries for ingenol mebutate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for INGENOL MEBUTATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Nova Scotia Health AuthorityPhase 4
Instituto Nacional de Cancer, BrazilPhase 1/Phase 2
Merete HaedersdalPhase 1/Phase 2

See all INGENOL MEBUTATE clinical trials

Generic filers with tentative approvals for INGENOL MEBUTATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial0.05%GEL; TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for INGENOL MEBUTATE
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
Paragraph IV (Patent) Challenges for INGENOL MEBUTATE
Tradename Dosage Ingredient NDA Submissiondate
PICATO GEL;TOPICAL ingenol mebutate 202833 2016-01-27

US Patents and Regulatory Information for INGENOL MEBUTATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for INGENOL MEBUTATE

Supplementary Protection Certificates for INGENOL MEBUTATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 132014902287215 Italy ⤷  Free Forever Trial PRODUCT NAME: INGENOLO MEBUTATO O UN SUO DERIVATO (SALE O ESTERE)(PICATO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/796/001-002, 20121119
1988877 C20140025 00111 Estonia ⤷  Free Forever Trial PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 C201430051 Spain ⤷  Free Forever Trial PRODUCT NAME: INGENOL MEBUTATO O UN DERIVADO ESTER DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
1015413 C01015413/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 C300682 Netherlands ⤷  Free Forever Trial PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 CA 2014 00042 Denmark ⤷  Free Forever Trial PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Medtronic
Colorcon
AstraZeneca
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.