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Last Updated: January 16, 2021

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AFINITOR Drug Profile

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When do Afinitor patents expire, and what generic alternatives are available?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and forty-nine patent family members in forty-seven countries.

The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Additional details are available on the everolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Afinitor

A generic version of AFINITOR was approved as everolimus by HIKMA on April 12th, 2018.

  Start Trial

Drug patent expirations by year for AFINITOR
Drug Prices for AFINITOR

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Recent Clinical Trials for AFINITOR

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

SponsorPhase
Pediatric Brain Tumor FoundationPhase 1
The Lilabean Foundation for Pediatric Brain Cancer ResearchPhase 1
University of California, San FranciscoPhase 1

See all AFINITOR clinical trials

Paragraph IV (Patent) Challenges for AFINITOR
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR TABLET;ORAL everolimus 022334 2014-12-10
AFINITOR TABLET;ORAL everolimus 022334 2014-06-18

US Patents and Regulatory Information for AFINITOR

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;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial Y   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 022334-002 Mar 30, 2009 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Start Trial   Start Trial   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 AFINITOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009   Start Trial   Start Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009   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
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 AFINITOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 SPC/GB10/003 United Kingdom   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTERED: SE SE 18690-18695 20030718; UK EU/1/09/538/001 20090803; UK EU/1/09/538/002 20090803; UK EU/1/09/538/003 20090803; UK EU/1/09/538/004 20090803; UK EU/1/09/538/005 20090803; UK EU/1/09/538/006 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
0663916 C300154 Netherlands   Start Trial PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
3342411 C03342411/01 Switzerland   Start Trial PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 17.01.2012
2269604 PA2016035,C2269604 Lithuania   Start Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3351246 CA 2019 00056 Denmark   Start Trial PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic
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