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 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
| International Patents: | 35 |
| US Patents: | 12 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Clinical Trials: | 50 |
| Patent Applications: | 978 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INGENOL MEBUTATE |
| What excipients (inactive ingredients) are in INGENOL MEBUTATE? | INGENOL MEBUTATE excipients list |
| 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 |
Generic filers with tentative approvals for INGENOL MEBUTATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 | 209019-001 | Jan 9, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Supplementary Protection Certificates for INGENOL MEBUTATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1988877 | PA2014030 | Lithuania | ⤷ Sign Up | PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115 |
| 1988877 | C201430051 | Spain | ⤷ Sign Up | 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 | 14C0058 | France | ⤷ Sign Up | PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119 |
| 1988877 | C01988877/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013 |
| 1015413 | C01015413/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
