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Ingenol mebutate - Generic Drug Details

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Ingenol mebutate is the generic ingredient in one branded drug marketed by Leo Pharma As 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.

This ingredient has forty-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 Generic Name: ingenol mebutate

Tradenames:1
Patents:11
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ingenol mebutate

Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYes6,844,013► subscribe ► subscribe
Leo Pharma As
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYes8,716,271► subscribe ► subscribe
Leo Pharma As
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYes8,716,271► subscribe ► subscribe
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International Patent Family for Ingredient: ingenol mebutate

Country Document Number Estimated Expiration
South Africa200805187► subscribe
Canada2301082► subscribe
Spain2461315► 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
2014 00042Denmark► subscribePRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
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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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