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Last Updated: July 11, 2020

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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 seven 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 eighty-eight patent family members in forty-eight countries.

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

Recent Clinical Trials for everolimus

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

SponsorPhase
National Cancer Institute, FrancePhase 2
Regeneron PharmaceuticalsPhase 1
Fudan UniversityPhase 2

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
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-002 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 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 ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   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
3351246 PA2019521 Lithuania   Start Trial PRODUCT NAME: REPAMICINO DARINYS, SKIRTAS KIETO NAVIKO, SISIJUSIO SU NEREGULIUOJAMA ANGIOGENEZE, GYDYMUI; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269604 122016000094 Germany   Start Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
2269603 PA2015041 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
McKesson
Medtronic
Moodys
Boehringer Ingelheim

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