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Orlistat - Generic Drug Details

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Orlistat is the generic ingredient in two branded drugs marketed by Hoffmann La Roche and Glaxosmithkline Cons, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-eight patent family members in thirty-three countries.

There are ten drug master file entries for orlistat. Three suppliers are listed for this compound.

Summary for Generic Name: orlistat

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list10
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: orlistat

Clinical Trials for: orlistat

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons
ALLI
orlistat
CAPSULE;ORAL021887-001Feb 7, 2007OTCYes6,004,996Jan 6, 2018Y
Hoffmann La Roche
XENICAL
orlistat
CAPSULE;ORAL020766-001Apr 23, 1999RXYes6,004,996*PEDJul 6, 2018Y
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Expired Orange Book Patents for Generic Ingredient: orlistat

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
XENICAL
orlistat
CAPSULE;ORAL020766-001Apr 23, 19994,598,089*PED<disabled>
Glaxosmithkline Cons
ALLI
orlistat
CAPSULE;ORAL021887-001Feb 7, 20074,598,089<disabled>
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International Patent Family for Ingredient: orlistat

Country Document Number Estimated Expiration
Germany69800639<disabled in preview>
Colombia4920214<disabled in preview>
Morocco24466<disabled in preview>
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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: ORLISTAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042Belgium<disabled>PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
C/GB98/044United Kingdom<disabled>PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
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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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