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Ingenol mebutate - Generic Drug Details
What are the generic drug sources for ingenol mebutate and what is the scope of ingenol mebutate patent protection?
Ingenol mebutate
is the generic ingredient in one branded drug marketed by Leo Labs and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for ingenol mebutate. One supplier is listed for this compound.
Summary for ingenol mebutate
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 22 |
| Clinical Trials: | 46 |
| Patent Applications: | 39 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ingenol mebutate |
| DailyMed Link: | ingenol mebutate at DailyMed |
Pharmacology for ingenol mebutate
| Drug Class | Cell Death Inducer |
| Physiological Effect | Increased Cellular Death |
Synonyms for ingenol mebutate
| (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-5,5a-Dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1a,2,5,5a,6,9,10,10a-octahydro-1H-2,8a- methanocyclopenta(a)cyclopropa(e)cyclodecen-6-yl (2Z)-2-methylbut-2-enoate |
| (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1a,2,5,5a,6,9,10,10a-octahydro-1H-2,8a-methanocyclopenta[a]cyclopropa[e][10]annulen-6-yl |
| (1S,4S,5S,6R,9S,10R,12R,14R)-5,6-DIHYDROXY-7-(HYDROXYMETHYL)-3,11,11,14-TETRAMETHYL-15-OXOTETRACYCLO[7.5.1.0(1),?.0(1)?,(1)(2)]PENTADECA-2,7-DIEN-4-YL (2Z)-2-METHYLBUT-2-ENOATE |
| (2Z)-2-Methyl-2-butenoic acid (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6-yl ester |
| (Z)-2-methylbut-2-enoate |
| [dihydroxy-(hydroxymethyl)-tetramethyl-oxo-[?]yl] (Z)-2-methylbut-2-enoate |
| 2-Butenoic acid, 2-methyl-, (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6-yl ester, (2Z)- |
| 3-Angeloylingenol |
| 3-Ingenyl angelate |
| 75567-37-2 |
| 7686S50JAH |
| 849146-39-0 |
| ACN-035815 |
| AKOS024457952 |
| AN-262 |
| CHEMBL1863513 |
| CS-2971 |
| D06HNG |
| D09393 |
| D0E9KA |
| DB05013 |
| Euphorbia factor An1 |
| Euphorbia factor H1 |
| GTPL7443 |
| HSDB 8308 |
| HY-B0719 |
| I3A |
| Ingenol 3-angelate |
| Ingenol mebutate (USAN) |
| Ingenol mebutate [USAN:INN] |
| Ingenol-3- angelate |
| Ingenol-3-angelate |
| Ingenol-3-angelate, >=95% (HPLC) |
| Ingenol-3-angelate; |
| MolPort-003-941-761 |
| PEP 005 |
| PEP-005 |
| PEP005 |
| Picato |
| Picato (TN) |
| PL008725 |
| POL-103A |
| SCHEMBL2526605 |
| UNII-7686S50JAH |
| VDJHFHXMUKFKET-WDUFCVPESA-N |
| ZINC100037855 |
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 | 202833-002 | Jan 23, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-001 | Jan 23, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | RX | Yes | Yes | ➤ 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 | 202833-001 | 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 |
| Leo Labs | PICATO | ingenol mebutate | GEL;TOPICAL | 202833-002 | Jan 23, 2012 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for ingenol mebutate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 20140088617 | ➤ Sign Up |
| Eurasian Patent Organization | 201201452 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 9908994 | ➤ Sign Up |
| Cyprus | 1115292 | ➤ Sign Up |
| Australia | PO864097 | ➤ Sign Up |
| Spain | 2461315 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ingenol mebutate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1015413/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013 |
| 0140025 00111 | Estonia | ➤ Sign Up | PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012 |
| 2014000075 | Germany | ➤ Sign Up | PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115 |
| 185 | Luxembourg | ➤ Sign Up | PRODUCT NAME: INGENANE OU UN DERIVE(SEL OU ESTER)DE CELUI-CI |
| 90022-0 | Sweden | ➤ Sign Up | PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115 |
| 5 | Finland | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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