Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
UBS
Federal Trade Commission
Healthtrust
Moodys
Argus Health
Medtronic
US Department of Justice
Harvard Business School

Generated: May 22, 2018

DrugPatentWatch Database Preview

Ingenol mebutate - Generic Drug Details

or, see our see our flat-rate plans

« Back to Dashboard

What are the generic sources for ingenol mebutate and what is the scope of ingenol mebutate freedom to operate?

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.

Ingenol mebutate has fifty-three patent family members in twenty-four countries.

There are three drug master file entries for ingenol mebutate. One supplier is listed for this compound.
Pharmacology for ingenol mebutate
Drug ClassCell Death Inducer
Physiological EffectIncreased 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 202833-001 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 202833-001 Jan 23, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Non-Orange Book US Patents for ingenol mebutate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,603,822 Therapeutic compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

Supplementary Protection Certificates for ingenol mebutate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000075 Germany ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1015413/01 Switzerland ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
00592 Netherlands ➤ Sign Up PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
90022-0 Sweden ➤ Sign Up PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Julphar
Fish and Richardson
Medtronic
Federal Trade Commission
Healthtrust
Moodys
Mallinckrodt
UBS

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.