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Serving leading biopharmaceutical companies globally:

Julphar
Novartis
Boehringer Ingelheim
Johnson and Johnson
Colorcon
Cerilliant
Chinese Patent Office
Healthtrust
Deloitte
Farmers Insurance

Generated: December 12, 2017

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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 twelve 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 and fourteen supplementary protection certificates in ten 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo LabsPICATOingenol mebutateGEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,603,822Therapeutic compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ingenol mebutate

Country Document Number Estimated Expiration
Canada2301082► Subscribe
South Korea20140088617► Subscribe
Portugal1015413► Subscribe
Australia736230► Subscribe
Australia2006325244► Subscribe
Slovenia1988877► Subscribe
HungaryE020998► Subscribe
European Patent Office2399571► Subscribe
New Zealand569197► Subscribe
Israel192221► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: INGENOL MEBUTATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00024Denmark► Subscribe
2014030Lithuania► SubscribePRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
1015413/01Switzerland► SubscribePRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
2014 00042Denmark► SubscribePRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
5Finland► Subscribe
2014000075Germany► SubscribePRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
00682Netherlands► SubscribePRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
90022-0Sweden► SubscribePRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
0140025 00111Estonia► SubscribePRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877/01Switzerland► SubscribePRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Julphar
Cantor Fitzgerald
Mallinckrodt
Colorcon
Cipla
Boehringer Ingelheim
US Department of Justice
Citi
AstraZeneca

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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