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TAMIFLU Drug Profile

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Which patents cover Tamiflu, and what substitute generic drugs are available?

Tamiflu is a drug marketed by Roche and is included in two NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-seven patent family members in twenty-eight countries.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

Summary for Tradename: TAMIFLU

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list6
Bulk Api Vendors: see list83
Clinical Trials: see list42
Patent Applications: see list3,044
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TAMIFLU at DailyMed

Pharmacology for Tradename: TAMIFLU

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 2011RXYesYes5,763,483*PED► SubscribeY► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 2007RXYesNo5,763,483*PED► SubscribeY► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-001Dec 14, 2000DISCNNoNo5,866,601*PED► Subscribe ► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 2007RXYesNo5,866,601*PED► Subscribe ► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 2011RXYesYes5,866,601*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: TAMIFLU

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 20115,866,601*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-001Oct 27, 19995,763,483*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 20115,952,375*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-003Jul 2, 20075,763,483*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-001Dec 14, 20005,952,375*PED► Subscribe
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Paragraph IV activity for: TAMIFLU

Drugname Dosage Strength RLD Submissiondate
oseltamivir phosphateOral Suspension6 mg/mLTamiflu6/18/2015
oseltamivir phosphateCapsules30 mg and 45 mgTamiflu8/2/2011
oseltamivir phosphateCapsule75 mgTamiflu11/15/2010

Non-Orange Book Patents for Tradename: TAMIFLU

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,952,375 Compounds and methods for synthesis and therapy► Subscribe
6,225,341 Compounds and methods for synthesis and therapy► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TAMIFLU

Country Document Number Estimated Expiration
Norway318455► Subscribe
China101172957► Subscribe
Portugal759917► Subscribe
Hong Kong1120494► Subscribe
Netherlands300105► 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: TAMIFLU

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90024-9Sweden► Subscribe
991Luxembourg► Subscribe
C031/2002Ireland► SubscribeSPC031/2002: 20021107, EXPIRES: 20160226
/2002Austria► SubscribePRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620
2002 00027Denmark► Subscribe
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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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