Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Harvard Business School
Covington
Healthtrust
Cantor Fitzgerald
Argus Health
Chubb
Federal Trade Commission
Medtronic
Cerilliant

Generated: August 20, 2017

DrugPatentWatch Database Preview

Everolimus - Generic Drug Details

« Back to Dashboard

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 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 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:11
Applicants:2
NDAs:3
Drug Master File Entries: see list10
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list649
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
AFINITOR
everolimus
TABLET;ORAL022334-002Mar 30, 2009RXYesYes► Subscribe► Subscribe► Subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-003Aug 29, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-004Mar 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-001Mar 30, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-003Jul 9, 2010RXYesNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-003Aug 29, 2012► Subscribe► Subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-002Apr 20, 2010► Subscribe► Subscribe
Novartis
AFINITOR
everolimus
TABLET;ORAL022334-003Jul 9, 2010► Subscribe► Subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-001Apr 20, 2010► Subscribe► Subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-001Aug 29, 2012► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: everolimus

Country Document Number Estimated Expiration
Czech Republic303006► Subscribe
CroatiaP20140708► Subscribe
European Patent Office2275103► Subscribe
United Kingdom0609912► Subscribe
Spain2288033► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Baxter
Deloitte
Teva
Healthtrust
Chubb
Colorcon
Daiichi Sankyo
Argus Health
Merck

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot