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Generated: June 25, 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 Roche, Nesher Pharms, Amneal Pharms, and Natco Pharma Ltd, and is included in five NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oseltamivir phosphate has fifty-seven patent family members in twenty-eight countries.

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

Summary for Generic Name: oseltamivir phosphate

Tradenames:2
Patents:3
Applicants:4
NDAs:5
Drug Master File Entries: see list7
Suppliers / Packagers: see list10
Bulk Api Vendors: see list45
Clinical Trials: see list862
Patent Applications: see list2,463
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oseltamivir phosphate at DailyMed

Pharmacology for Ingredient: oseltamivir phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
OSELTAMIVIR PHOSPHATE
oseltamivir phosphate
CAPSULE;ORAL209093-003May 17, 2017ABRXNoNo► Subscribe► Subscribe
Natco Pharma Ltd
OSELTAMIVIR PHOSPHATE
oseltamivir phosphate
CAPSULE;ORAL202595-002Aug 3, 2016ABRXNoNo► Subscribe► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 2007ABRXYesNo5,866,601*PED► Subscribe ► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-003Jul 2, 2007ABRXYesNo5,866,601*PED► Subscribe ► Subscribe
Nesher Pharms
OSELTAMIVIR PHOSPHATE
oseltamivir phosphate
CAPSULE;ORAL208578-003Feb 24, 2017ABRXNoNo► 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
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-001Oct 27, 19995,763,483*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-001Dec 14, 20005,866,601*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 20115,763,483*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-001Oct 27, 19995,866,601*PED► Subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 20075,952,375*PED► 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
Hong Kong1120494► Subscribe
Germany69607704► Subscribe
Portugal759917► Subscribe
Australia720933► Subscribe
Germany69635231► 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
/2002Austria► SubscribePRODUCT NAME: OSELTAMIVIR PHOSPHAT; REGISTRATION NO/DATE: EU/1/02/222/001 EU/1/02/222/002 20020620
991Luxembourg► Subscribe
90024-9Sweden► Subscribe
C031/2002Ireland► SubscribeSPC031/2002: 20021107, EXPIRES: 20160226
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
US Department of Justice
Cantor Fitzgerald
Covington
Argus Health
Citi
QuintilesIMS
Cipla
Dow
Baxter

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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