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Last Updated: June 14, 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 five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-nine patent family members in thirty-one countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Afinitor

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

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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   Get Started Free   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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 022334-002 Mar 30, 2009   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009   Get Started Free   Get Started Free
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009   Get Started Free   Get Started Free
>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
3351246 PA2019521 Lithuania   Get Started Free PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
3143995 2019C/528 Belgium   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3143995 PA2019511 Lithuania   Get Started Free PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526
3143995 300992 Netherlands   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246 2019C/550 Belgium   Get Started Free DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
2269603 132015000073030 Italy   Get Started Free PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): C(2012)5347, 20120725
2269604 2016C/075 Belgium   Get Started Free DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Express Scripts
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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