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Last Updated: March 28, 2024

Everolimus - Generic Drug Details


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What are the generic drug sources for everolimus and what is the scope of patent protection?

Everolimus is the generic ingredient in four branded drugs marketed by Novartis Pharm, Mylan, Novartis, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Hikma, Par Pharm, and Teva Pharms Usa, and is included in fourteen NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twelve drug master file entries for everolimus. Nine suppliers are listed for this compound.

Drug Prices for everolimus

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Recent Clinical Trials for everolimus

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

SponsorPhase
Nationwide Children's HospitalPhase 2
University of MiamiPhase 2
University of Wisconsin, MadisonPhase 2

See all everolimus clinical trials

Medical Subject Heading (MeSH) Categories for everolimus
Paragraph IV (Patent) Challenges for EVEROLIMUS
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
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
ZORTRESS Tablets everolimus 0.25 mg, 0.5 mg, and 0.75 mg 021560 3 2013-09-30

US Patents and Regulatory Information for everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma EVEROLIMUS everolimus TABLET;ORAL 206133-001 Apr 12, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge EVEROLIMUS everolimus TABLET;ORAL 205426-001 Mar 5, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa EVEROLIMUS everolimus TABLET;ORAL 210050-003 Dec 9, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge EVEROLIMUS everolimus TABLET;ORAL 205426-003 Mar 5, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biocon Pharma EVEROLIMUS everolimus TABLET;ORAL 214182-002 Feb 11, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge EVEROLIMUS everolimus TABLET;ORAL 205432-001 May 20, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm EVEROLIMUS everolimus TABLET;ORAL 207934-003 Dec 9, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 everolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for everolimus

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 everolimus

Country Patent Number Title Estimated Expiration
Israel 259724 ⤷  Try a Trial
European Patent Office 2275103 Inhibiteurs du mTOR pour le traitement des tumeurs endocriniennes (mTOR inhibitors in the treatment of endocrine tumors) ⤷  Try a Trial
Denmark 2269603 ⤷  Try a Trial
Slovakia 288524 ⤷  Try a Trial
Denmark 2275103 ⤷  Try a Trial
United Kingdom 0609912 ⤷  Try a Trial
Russian Federation 2018127821 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for everolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3143995 34/2019 Austria ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2016) 3286 (MITTEILUNG) 20160530
3143995 2019C/528 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
3143995 122019000051 Germany ⤷  Try a Trial 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
2269604 93320 Luxembourg ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538-001-006 - AFINITOR - EVEROLIMUS
2269604 2016C/075 Belgium ⤷  Try a Trial DETAILS LICENCE: LICENCE, ENREGISTREMENT D'UNE NOUVELLE LICENCE
3342411 C03342411/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 17.01.2012
0663916 122004000033 Germany ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: 58387.00.00 58387.00.01 58387.01.00 58387.01.01 58387.02.00 58387.03.00 20040204 FIRST REGISTRATION: SCHWEDEN 18690 18691 18692 18693 18694 18695 20030718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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