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Serving leading biopharmaceutical companies globally:

UBS
McKinsey
Chubb
US Army
Dow
Cantor Fitzgerald
Farmers Insurance
Cipla
Healthtrust
Moodys

Generated: December 18, 2017

DrugPatentWatch Database Preview

AFINITOR Drug Profile

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When do Afinitor patents expire, and when can generic versions of Afinitor launch?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and fourteen patent family members in forty countries.

The generic ingredient in AFINITOR is everolimus. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PharmAFINITOR DISPERZeverolimusTABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-004Mar 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-004Mar 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: AFINITOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-004Mar 30, 2012► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-003Jul 9, 2010► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for AFINITOR

Drugname Dosage Strength RLD Submissiondate
everolimusTablets for Oral Suspension2 mg, 3 mg and 5 mgAfinitor Disperz12/30/2016
everolimusTablets2.5 mg, 5 mg, and 7.5 mgAfinitor12/10/2014
everolimusTablets10 mgAfinitor6/18/2014

Non-Orange Book Patents for Tradename: AFINITOR

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
6,605,613 Macrolides► Subscribe
7,572,804Macrolides► Subscribe
6,852,729 Macrolides► 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: AFINITOR

Country Document Number Estimated Expiration
European Patent Office1954269► Subscribe
Hungary228939► Subscribe
Canada2933875► Subscribe
European Patent Office1137439► Subscribe
Japan2009516671► Subscribe
Poland348333► Subscribe
United Kingdom0602747► Subscribe
Belgium1012869► Subscribe
United Kingdom0523658► Subscribe
Japan5043308► 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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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Argus Health
Daiichi Sankyo
Fuji
Moodys
Queensland Health
AstraZeneca
Merck
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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