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Last Updated: July 15, 2020

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INGENOL MEBUTATE - Generic Drug Details

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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 thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ingenol mebutate has fifty-four patent family members in twenty-five 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
Instituto Nacional de Cancer, BrazilPhase 1/Phase 2
Merete HaedersdalPhase 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
  Start Trial  Start 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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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

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

Supplementary Protection Certificates for INGENOL MEBUTATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1015413 C300592 Netherlands   Start Trial PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
1988877 300682 Netherlands   Start Trial PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 C01988877/01 Switzerland   Start Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 14C0058 France   Start Trial PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 132014902287215 Italy   Start 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 C 2014 032 Romania   Start Trial 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Baxter
Medtronic
Merck
McKinsey

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