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Last Updated: June 24, 2022

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
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
See Plans and PricingSee Plans and Pricing0.05%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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
>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
Denmark 1988877 See Plans and Pricing
Eurasian Patent Organization 201201452 ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ See Plans and Pricing
South Korea 20140088617 THERAPEUTIC COMPOSITIONS See Plans and Pricing
United Kingdom 0525680 See Plans and Pricing
Japan 2013049715 THERAPEUTIC COMPOSITION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ingenol mebutate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 14C0058 France See Plans and Pricing PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 C201430051 Spain See Plans and Pricing 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 46/2014 Austria See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877 2014C/045 Belgium See Plans and Pricing PRODUCT NAME: MEBUTATE D'INGENOL OU L'UN DE SES DERIVES (SELS OU ESTER); AUTHORISATION NUMBER AND DATE: EU/1/12/796 20121119
1988877 C20140025 00111 Estonia See Plans and Pricing PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Medtronic
Express Scripts
AstraZeneca
Moodys

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