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Serving leading biopharmaceutical companies globally:

US Department of Justice
Dow
Colorcon
Julphar
Fuji
Deloitte
Johnson and Johnson
Cipla
Harvard Business School
Chinese Patent Office

Generated: December 12, 2017

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Oseltamivir phosphate - Generic Drug Details

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What are the generic drug sources for oseltamivir phosphate and what is the scope of oseltamivir phosphate freedom to operate?

Oseltamivir phosphate
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Macleods Pharms Ltd, Natco Pharma Ltd, Nesher Pharms, Roche, and Alvogen Pine Brook, and is included in eight NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oseltamivir phosphate has sixty patent family members in twenty-eight countries and five supplementary protection certificates in five countries.

There are seven drug master file entries for oseltamivir phosphate. Fifteen suppliers are listed for this compound.

Pharmacology for oseltamivir phosphate

Medical Subject Heading (MeSH) Categories for oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms LtdOSELTAMIVIR PHOSPHATEoseltamivir phosphateCAPSULE;ORAL207211-003Sep 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-001Dec 14, 2000DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Amneal PharmsOSELTAMIVIR PHOSPHATEoseltamivir phosphateCAPSULE;ORAL209093-002May 17, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Natco Pharma LtdOSELTAMIVIR PHOSPHATEoseltamivir phosphateCAPSULE;ORAL202595-003Aug 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsOSELTAMIVIR PHOSPHATEoseltamivir phosphateCAPSULE;ORAL209093-003May 17, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-003Jul 2, 2007ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-002Mar 21, 2011ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nesher PharmsOSELTAMIVIR PHOSPHATEoseltamivir phosphateCAPSULE;ORAL208578-003Feb 24, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-001Dec 14, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-002Jul 2, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-002Mar 21, 2011► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-002Jul 2, 2007► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-002Mar 21, 2011► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-001Oct 27, 1999► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-003Jul 2, 2007► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-001Dec 14, 2000► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-002Jul 2, 2007► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-001Oct 27, 1999► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateCAPSULE;ORAL021087-002Jul 2, 2007► Subscribe► Subscribe
RocheTAMIFLUoseltamivir phosphateFOR SUSPENSION;ORAL021246-001Dec 14, 2000► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: oseltamivir phosphate

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 Ingredient: oseltamivir phosphate

Country Document Number Estimated Expiration
Hungary229200► Subscribe
China1185223► Subscribe
Hong Kong1088594► Subscribe
Japan4234917► Subscribe
Georgia, Republic ofP20074226► Subscribe
China1733707► Subscribe
Hong Kong1026893► Subscribe
Hungary9800026► Subscribe
China102952033► Subscribe
Spain2118674► 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: OSELTAMIVIR PHOSPHATE

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

Julphar
McKinsey
Express Scripts
Baxter
Merck
Fish and Richardson
Cantor Fitzgerald
Mallinckrodt
Dow
McKesson

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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