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Serving leading biopharmaceutical companies globally:

McKesson
Farmers Insurance
Argus Health
Moodys
Cantor Fitzgerald
Teva
US Army
Cerilliant
Johnson and Johnson
Baxter

Generated: December 17, 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 Pharm and Novartis, and is included in three NDAs. There are eleven 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 fourteen patent family members in forty countries.

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

Medical Subject Heading (MeSH) Categories for everolimus

Tentative approvals for EVEROLIMUS

Applicant Application No. Strength Dosage Form
u► 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
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-004Mar 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-001Apr 20, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-002Apr 20, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-001Apr 20, 2010RXYesNo► Subscribe► SubscribeY► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-003Jul 9, 2010RXYesNo► Subscribe► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-003Apr 20, 2010RXYesYes► Subscribe► 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 PharmAFINITOR DISPERZeverolimusTABLET, FOR SUSPENSION;ORAL203985-003Aug 29, 2012► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-002Apr 20, 2010► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-003Apr 20, 2010► Subscribe► Subscribe
Novartis PharmAFINITOR DISPERZeverolimusTABLET, FOR SUSPENSION;ORAL203985-001Aug 29, 2012► Subscribe► Subscribe
Novartis PharmAFINITOR DISPERZeverolimusTABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 2012► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-001Apr 20, 2010► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-003Apr 20, 2010► Subscribe► Subscribe
NovartisAFINITOReverolimusTABLET;ORAL022334-002Mar 30, 2009► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-002Apr 20, 2010► Subscribe► Subscribe
NovartisZORTRESSeverolimusTABLET;ORAL021560-001Apr 20, 2010► Subscribe► 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
United Kingdom0609912► Subscribe
Malaysia127579► Subscribe
Norway20121113► Subscribe
South Africa200104360► Subscribe
Japan2009516671► Subscribe
Japan5165199► Subscribe
New Zealand604127► Subscribe
TaiwanI248938► Subscribe
World Intellectual Property Organization (WIPO)0033878► Subscribe
Israel143092► 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:

McKesson
Dow
Federal Trade Commission
AstraZeneca
Merck
Boehringer Ingelheim
QuintilesIMS
Chubb
US Department of Justice
Daiichi Sankyo

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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