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Serving leading biopharmaceutical companies globally:

Dow
Accenture
Cantor Fitzgerald
Fish and Richardson
Cipla
Healthtrust
Novartis
Medtronic
US Department of Justice
McKesson

Generated: February 21, 2018

DrugPatentWatch Database Preview

Ingenol mebutate - Generic Drug Details

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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.
Summary for ingenol mebutate
Pharmacology for ingenol mebutate
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death

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 Y ➤ 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 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 ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 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

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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

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International Patents for ingenol mebutate

Supplementary Protection Certificates for ingenol mebutate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140025 00111 Estonia ➤ Sign Up PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
2014 00042 Denmark ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
2013 00024 Denmark ➤ Sign Up
185 Luxembourg ➤ Sign Up PRODUCT NAME: INGENANE OU UN DERIVE(SEL OU ESTER)DE CELUI-CI
2014030 Lithuania ➤ Sign Up PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
00592 Netherlands ➤ Sign Up PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
C0058 France ➤ Sign Up PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413/01 Switzerland ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
90022-0 Sweden ➤ Sign Up PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
0682 Netherlands ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Teva
Argus Health
Baxter
Julphar
Cipla
Chinese Patent Office
McKinsey

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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