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Last Updated: April 17, 2021

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Everolimus - Generic Drug Details

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What are the generic sources for everolimus and what is the scope of freedom to operate?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Hikma, Par Pharm, and Teva Pharms Usa, and is included in nine NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Everolimus has three hundred and ninety-seven patent family members in forty-eight countries.

There are twelve drug master file entries for everolimus. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for everolimus

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Recent Clinical Trials for everolimus

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hoffmann-La RochePhase 1/Phase 2
Second Affiliated Hospital of Guangzhou Medical UniversityN/A
The Hospital for Sick ChildrenN/A

See all everolimus clinical trials

Generic filers with tentative approvals for EVEROLIMUS
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial7.5MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial2.5MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for everolimus
Paragraph IV (Patent) Challenges for EVEROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR DISPERZ TABLET, FOR SUSPENSION;ORAL everolimus 203985 2016-12-30
AFINITOR TABLET;ORAL everolimus 022334 2014-12-10
AFINITOR TABLET;ORAL everolimus 022334 2014-06-18
ZORTRESS TABLET;ORAL everolimus 021560 2013-09-30

US Patents and Regulatory Information for everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm EVEROLIMUS everolimus TABLET;ORAL 207934-001 Dec 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm EVEROLIMUS everolimus TABLET;ORAL 207934-004 Dec 9, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
Mylan EVEROLIMUS everolimus TABLET;ORAL 212936-004 Jun 8, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-001 Apr 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for everolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3342411 LUC00148 Luxembourg   Start Trial PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830
2269604 PA2016035 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
2269603 CA 2015 00058 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3143995 300992 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246 CA 2019 00056 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3351246 301018 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3143995 2019C/528 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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