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XENICAL Drug Profile

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Xenical is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug.

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

The generic ingredient in XENICAL is orlistat. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.

Summary for Tradename: XENICAL

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: XENICAL

Clinical Trials for: XENICAL

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>
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Expired Patents for Tradename: XENICAL

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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>
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International Patent Family for Tradename: XENICAL

Country Document Number Estimated Expiration
Indonesia26509<disabled in preview>
South Africa9800746<disabled in preview>
Israel126902<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: XENICAL

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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