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Last Updated: November 22, 2024

Ingenol mebutate - Generic Drug Details


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What are the generic sources for ingenol mebutate and what is the scope of freedom to operate?

Ingenol mebutate is the generic ingredient in two branded drugs marketed by Padagis Israel 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. There is one tentative approval for this compound.

Summary for ingenol mebutate
International Patents:35
US Patents:12
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 3
Raw Ingredient (Bulk) Api Vendors: 65
Clinical Trials: 50
Patent Applications: 978
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for ingenol mebutate
What excipients (inactive ingredients) are in ingenol mebutate?ingenol mebutate excipients list
DailyMed Link:ingenol mebutate at DailyMed
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
University of California, San FranciscoPhase 1

See all ingenol mebutate clinical trials

Generic filers with tentative approvals for INGENOL MEBUTATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up0.05%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.

Paragraph IV (Patent) Challenges for INGENOL MEBUTATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PICATO Gel ingenol mebutate 0.015% 202833 2 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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ingenol mebutate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
LEO Laboratories Ltd. Picato ingenol mebutate EMEA/H/C/002275
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.
Withdrawn no no no 2012-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ingenol mebutate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 200870063 ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2013171258 ⤷  Sign Up
Norway 20083150 ⤷  Sign Up
Mexico 2008007685 COMPOSICIONES TERAPEUTICAS. (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE.) ⤷  Sign Up
South Korea 20140088617 THERAPEUTIC COMPOSITIONS ⤷  Sign Up
United Kingdom 0525680 ⤷  Sign Up
Hungary E020998 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ingenol mebutate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 C201430051 Spain ⤷  Sign Up 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
1988877 C20140025 00111 Estonia ⤷  Sign Up PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 46/2014 Austria ⤷  Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877 122014000075 Germany ⤷  Sign Up PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1015413 C01015413/01 Switzerland ⤷  Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 PA2014030 Lithuania ⤷  Sign Up PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
1988877 C 2014 032 Romania ⤷  Sign Up PRODUCT NAME: INGENOL MEBUTAT; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF NATIONAL AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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