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Last Updated: July 15, 2024

AFINITOR DISPERZ Drug Patent Profile


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Which patents cover Afinitor Disperz, and when can generic versions of Afinitor Disperz launch?

Afinitor Disperz is a drug marketed by Novartis Pharm and is included in one NDA.

The generic ingredient in AFINITOR DISPERZ 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 Disperz

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

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Drug patent expirations by year for AFINITOR DISPERZ
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Recent Clinical Trials for AFINITOR DISPERZ

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 3

See all AFINITOR DISPERZ clinical trials

Paragraph IV (Patent) Challenges for AFINITOR DISPERZ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AFINITOR DISPERZ Tablets for Oral Suspension everolimus 2 mg, 3 mg and 5 mg 203985 1 2016-12-30

US Patents and Regulatory Information for AFINITOR DISPERZ

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

FDA Regulatory Exclusivity protecting AFINITOR DISPERZ

FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
Exclusivity Expiration: ⤷  Sign Up

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 203985-001 Aug 29, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 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 DISPERZ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 ⤷  Sign Up ⤷  Sign Up
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AFINITOR DISPERZ

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 DISPERZ

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

Country Patent Number Title Estimated Expiration
Mexico 2019010879 TRATAMIENTO DE CANCER. (CANCER TREATMENT.) ⤷  Sign Up
Slovakia 287325 ⤷  Sign Up
Russian Federation 2013119705 ⤷  Sign Up
Israel 229156 40-o-(2-הידרוקסיאתיל)-ראפאמיצין ותכשירים רוקחיים הכוללים אותו לשימוש בטיפול בגידולים מוצקים דל מערכת ההפרשה (40-o-(2-hydroxyethyl)-rapamycin and pharmaceutical compositions comprising same for use in the treatment of solid excretory system tumors) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AFINITOR DISPERZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0663916 C00663916/01 Switzerland ⤷  Sign Up PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
2269603 2015C/060 Belgium ⤷  Sign Up DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
2269604 PA2016035,C2269604 Lithuania ⤷  Sign Up PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
0663916 14/2004 Austria ⤷  Sign Up PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN); NAT. REGISTRATION NO/DATE: 1-25271;1-25272; 1-25275,1-25276. 20040302; FIRST REGISTRATION: SE 18690;18691;18692; 18693;18694;18695. 20030718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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