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Last Updated: March 28, 2024

INGENOL MEBUTATE Drug Patent Profile


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Which patents cover Ingenol Mebutate, and when can generic versions of Ingenol Mebutate launch?

Ingenol Mebutate is a drug marketed by Padagis Israel and is included in two NDAs.

The generic ingredient in INGENOL MEBUTATE is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.

Drug patent expirations by year 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

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
Padagis Israel INGENOL MEBUTATE ingenol mebutate GEL;TOPICAL 209018-001 Jan 7, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Israel INGENOL MEBUTATE ingenol mebutate GEL;TOPICAL 209019-001 Jan 9, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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Withdrawn no no no 2012-11-15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

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