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Last Updated: July 25, 2024

AFINITOR Drug Patent Profile


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When do Afinitor patents expire, and when can generic versions of Afinitor launch?

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are two 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. Ten 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
Fudan UniversityPhase 3
Nationwide Children's HospitalPhase 2
Stemline Therapeutics, Inc.Phase 1/Phase 2

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.

Patents protecting AFINITOR

Neuroendocrine tumor treatment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

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 022334-003 Jul 9, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 ⤷  Sign Up ⤷  Sign Up
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AFINITOR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Afinitor everolimus EMEA/H/C/001038
Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Authorised no no no 2009-08-02
Novartis Europharm Limited Votubia everolimus EMEA/H/C/002311
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.
Authorised no no no 2011-09-02
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AFINITOR

See the table below for patents covering AFINITOR around the world.

Country Patent Number Title Estimated Expiration
Austria 310519 ⤷  Sign Up
Russian Federation 2325906 ЛЕЧЕНИЕ РАКА (CANCER MEDICAL TREATMENT) ⤷  Sign Up
China 1679559 ⤷  Sign Up
China 104274442 ⤷  Sign Up
Japan 2016222705 癌の処置 (CANCER TREATMENT) ⤷  Sign Up
Japan 2017081979 癌の処置 (TREATMENT OF CANCERS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AFINITOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3342411 C03342411/01 Switzerland ⤷  Sign Up PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 17.01.2012
3143995 300992 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3143995 122019000051 Germany ⤷  Sign Up 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
3342411 LUC00148 Luxembourg ⤷  Sign Up PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20110830
0663916 SPC/GB10/003 United Kingdom ⤷  Sign Up 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
2269604 122016000094 Germany ⤷  Sign Up PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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