INGENOL MEBUTATE Drug Patent Profile
✉ Email this page to a colleague
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.
Summary for INGENOL MEBUTATE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 50 |
Patent Applications: | 543 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INGENOL MEBUTATE |
DailyMed Link: | INGENOL MEBUTATE at DailyMed |
Recent Clinical Trials for INGENOL MEBUTATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nova Scotia Health Authority | Phase 4 |
Instituto Nacional de Cancer, Brazil | Phase 1/Phase 2 |
University of California, San Francisco | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for INGENOL MEBUTATE
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 |