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Serving 500+ biopharmaceutical companies globally:

Novartis
Moodys
US Army
Citi
Cipla
Deloitte
McKinsey
Julphar
Dow
AstraZeneca

Generated: June 25, 2017

DrugPatentWatch Database Preview

Everolimus - Generic Drug Details

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What are the generic sources for everolimus and what is the scope of everolimus patent protection?

Everolimus
is the generic ingredient in three branded drugs marketed by Novartis and Novartis Pharm, and is included in three NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Everolimus has one hundred and five patent family members in thirty-nine countries.

There are ten drug master file entries for everolimus. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: everolimus

Tradenames:3
Patents:12
Applicants:2
NDAs:3
Drug Master File Entries: see list10
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list646
Patent Applications: see list12,386
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:everolimus at DailyMed

Tentative approvals for EVEROLIMUS

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2.5MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 2012RXYesNo► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-004Mar 30, 2012RXYesNo► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-003Jul 9, 2010RXYesNo► Subscribe► Subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-002Apr 20, 2010RXYesNo5,665,772*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-003Apr 20, 20106,004,973*PED► Subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 20126,004,973*PED► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-003Jul 9, 20106,004,973*PED► Subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-003Apr 20, 20106,440,990*PED► Subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-001Apr 20, 20106,440,990*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: everolimus

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 Ingredient: everolimus

Country Document Number Estimated Expiration
Japan2009516671► Subscribe
Czech Republic20012001► Subscribe
New Zealand527781► Subscribe
China1261163► Subscribe
World Intellectual Property Organization (WIPO)2007057457► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Novartis
Cipla
Deloitte
AstraZeneca
Baxter
Colorcon
Express Scripts
US Department of Justice
Chinese Patent Office

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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