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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 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.
Summary for ingenol mebutate
International Patents: | 54 |
US Patents: | 13 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 29 |
Clinical Trials: | 49 |
Patent Applications: | 1,501 |
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 |
---|---|
Instituto Nacional de Cancer, Brazil | Phase 1/Phase 2 |
Merete Haedersdal | Phase 1/Phase 2 |
University of California, San Francisco | Phase 1 |
Generic filers with tentative approvals for INGENOL MEBUTATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 0.05% | 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 Class | Cell Death Inducer |
Physiological Effect | Increased 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 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | DISCN | Yes | No | Start Trial | Start Trial | 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 | 202833-002 | Jan 23, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ingenol mebutate
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2461315 | Start Trial |
Eurasian Patent Organization | 200870063 | Start Trial |
Cyprus | 1115292 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ingenol mebutate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1988877 | 300682 | Netherlands | Start Trial | PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119 |
1015413 | CA 2013 00024 | Denmark | Start Trial | |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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