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Last Updated: June 3, 2023

Everolimus - Generic Drug Details


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What are the generic sources for everolimus and what is the scope of freedom to operate?

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 five 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 seventy-seven patent family members in thirty-eight countries.

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

Drug Prices for everolimus

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Recent Clinical Trials for everolimus

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

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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
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alkem Labs Ltd EVEROLIMUS everolimus TABLET;ORAL 214138-003 Nov 26, 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
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-002 Apr 19, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-003 Apr 19, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Breckenridge EVEROLIMUS everolimus TABLET;ORAL 205426-002 Mar 5, 2021 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 022334-001 Mar 30, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 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 022334-003 Jul 9, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 ⤷  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 yes 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
Morocco 29966 TRAITEMENT DES TUMEURS NEUROENDOCRINES ⤷  Try a Trial
Norway 20190290 ⤷  Try a Trial
Denmark 2269603 ⤷  Try a Trial
Japan 2009516671 ⤷  Try a Trial
European Patent Office 1954269 TRAITEMENT DES TUMEURS NEUROENDOCRINES (NEUROENDOCRINE TUMOR TREATMENT USING MTOR INHIBITORS) ⤷  Try a Trial
Denmark 3351246 ⤷  Try a Trial
Israel 191475 שימוש ב- 40-o-(2-hydroxyethyl)-rapamycin להכנת תרופה לטיפול בגידולים נוירואנדוקריניים בלבלב (Use of 40-o-(2-hydroxyethyl)-rapamycin for the manufacture of a medicament for the treatment of pancreatic neuroendocrine tumors) ⤷  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
2269604 132016000127697 Italy ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(AFINITOR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/538/001-006, 20090805
3342411 PA2020503 Lithuania ⤷  Try a Trial PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538 20110824
2269603 CA 2015 00058 Denmark ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
2269603 300769 Netherlands ⤷  Try a Trial 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
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
3342411 301032 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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