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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Dow
Merck
Boehringer Ingelheim
Fuji
Cantor Fitzgerald
Fish and Richardson
Healthtrust
US Department of Justice
Citi

Generated: August 22, 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 eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ingenol mebutate has forty-six 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 Generic Name: ingenol mebutate

Tradenames:1
Patents:11
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list47
Patent Applications: see list29
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ingenol mebutate at DailyMed

Pharmacology for Ingredient: 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 Product Substance Delist Req. Exclusivity Expiration
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► 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
United Kingdom0525680► Subscribe
Australia736230► Subscribe
Japan5709826► Subscribe
World Intellectual Property Organization (WIPO)2007068963► Subscribe
HungaryE020998► 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
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
C0058France► SubscribePRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
0140025 00111Estonia► SubscribePRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
2013 00024Denmark► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Merck
Harvard Business School
Express Scripts
US Department of Justice
Citi
Argus Health
US Army
Julphar
AstraZeneca
Cantor Fitzgerald

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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