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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

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
Hoffmann La Roche
XENICAL
orlistat
CAPSULE;ORAL020766-001Apr 23, 1999RXYes6,004,996*PED<disabled>Y<disabled>
Glaxosmithkline Cons
ALLI
orlistat
CAPSULE;ORAL021887-001Feb 7, 2007OTCYes6,004,996<disabled>Y <disabled>
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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
Russian Federation2170579<disabled in preview>
Argentina010704<disabled in preview>
China1220600<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
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
C0042Belgium<disabled>PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
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