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Last Updated: May 21, 2022

AFINITOR Drug Patent 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. Eight 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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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
M.D. Anderson Cancer CenterEarly Phase 1
The Lilabean Foundation for Pediatric Brain Cancer ResearchPhase 1
Pediatric Brain Tumor FoundationPhase 1

See all AFINITOR clinical trials

Paragraph IV (Patent) Challenges for AFINITOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AFINITOR Tablets everolimus 2.5 mg, 5 mg, and 7.5 mg 022334 1 2014-12-10
AFINITOR Tablets everolimus 10 mg 022334 1 2014-06-18

US Patents and Regulatory Information for AFINITOR

AFINITOR is protected by one US patents and one FDA Regulatory Exclusivity.

Patents protecting AFINITOR

Neuroendocrine tumor treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH PROGESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

FDA Regulatory Exclusivity protecting AFINITOR

TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
Exclusivity Expiration: See Plans and Pricing

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 See Plans and Pricing See Plans and Pricing
>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
3143995 122019000051 Germany See Plans and Pricing PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/007 EU/1/09/538/008 EU/1/09/538/009 EU/1/09/538/010 20160526
3143995 PA2019511 Lithuania See Plans and Pricing PRODUCT NAME: EVEROLIMUZAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/09/538/001, 003, 004, 006-010 20160526
0663916 CA 2004 00020 Denmark See Plans and Pricing PRODUCT NAME: EVEROLIMUS
3351246 122019000102 Germany See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269603 300769 Netherlands See Plans and Pricing PRODUCT NAME: EVEROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/001, 003, 004 EN 006-010 (C(2012)5347) 20120725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Express Scripts
Dow
Merck
AstraZeneca

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