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Serving leading biopharmaceutical companies globally:

Cipla
US Department of Justice
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Teva
Moodys
Johnson and Johnson
Fuji
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Generated: November 23, 2017

DrugPatentWatch Database Preview

Orlistat - Generic Drug Details

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What are the generic sources for orlistat and what is the scope of orlistat freedom to operate?

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.

Orlistat has forty patent family members in thirty-three countries and two supplementary protection certificates in two countries.

There are eleven drug master file entries for orlistat. Two suppliers are listed for this compound.

Pharmacology for orlistat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Cons
ALLI
orlistat
CAPSULE;ORAL021887-001Feb 7, 2007OTCYesYes► Subscribe► SubscribeY ► Subscribe
Hoffmann La Roche
XENICAL
orlistat
CAPSULE;ORAL020766-001Apr 23, 1999RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: orlistat

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
XENICAL
orlistat
CAPSULE;ORAL020766-001Apr 23, 1999► Subscribe► Subscribe
Glaxosmithkline Cons
ALLI
orlistat
CAPSULE;ORAL021887-001Feb 7, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: orlistat

Country Document Number Estimated Expiration
Norway985337► Subscribe
Yugoslavia49698► Subscribe
China1193752► Subscribe
Yugoslavia49423► Subscribe
European Patent Office0921796► Subscribe
Spain2156028► Subscribe
Greece3036064► Subscribe
Israel126902► Subscribe
Slovenia0921796► Subscribe
JapanH11255645► 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: ORLISTAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042Belgium► SubscribePRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
C/GB98/044United Kingdom► SubscribePRODUCT 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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Serving leading biopharmaceutical companies globally:

US Army
Colorcon
Dow
Cantor Fitzgerald
Moodys
Chubb
Daiichi Sankyo
Cerilliant
Argus Health
Teva

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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