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Last Updated: November 27, 2022

Ingenol mebutate - Generic Drug Details


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

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 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 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 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

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
South Korea 20080092373 THERAPEUTIC COMPOSITIONS See Plans and Pricing
Denmark 1988877 See Plans and Pricing
Slovenia 1988877 See Plans and Pricing
Eurasian Patent Organization 024152 КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ВВЕДЕНИЯ ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ РАКА КОЖИ (TOPICAL COMPOSITION FOR TREATING OR PREVENTING SKIN CANCER) See Plans and Pricing
United Kingdom 0525680 See Plans and Pricing
Israel 192221 תכשירים רפואיים המכילים angelate- 3- ingenol (Therapeutic compositions comprising ingenol-3-angelate) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2007068963 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 122014000075 Germany See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877 C01988877/01 Switzerland See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 C20140025 00111 Estonia See Plans and Pricing PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 300682 Netherlands See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413 C01015413/01 Switzerland See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 PA2014030 Lithuania See Plans and Pricing PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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