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Last Updated: April 24, 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
National Institute on Aging (NIA)Phase 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
Teva Pharms Usa EVEROLIMUS everolimus TABLET;ORAL 210050-002 Dec 9, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma EVEROLIMUS everolimus TABLET;ORAL 206133-002 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
Novartis AFINITOR everolimus TABLET;ORAL 022334-002 Mar 30, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm EVEROLIMUS everolimus TABLET;ORAL 205775-001 Oct 18, 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 ZORTRESS everolimus TABLET;ORAL 021560-002 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 022334-002 Mar 30, 2009 ⤷  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
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 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
>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
Russian Federation 2008124827 ЛЕЧЕНИЕ НЕЙРОЭНДОКРИННЫХ ОПУХОЛЕЙ ⤷  Try a Trial
Lithuania PA2020503 ⤷  Try a Trial
Japan 2018100282 癌の処置 (CANCER TREATMENT) ⤷  Try a Trial
Norway 20150413 ⤷  Try a Trial
Norway 339240 ⤷  Try a Trial
Lithuania 2762140 ⤷  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
3351246 CA 2019 00056 Denmark ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
3143995 2019C/528 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
2269603 122015000094 Germany ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001 20120723
0663916 C300154 Netherlands ⤷  Try a Trial PRODUCT NAME: EVEROLIMUSUM; NAT. REGISTRATION NO/DATE: RVG 30041RVG 30042RVG 30043RVG 30044RVG 30045RVG 30046 2004100610; FIRST REGISTRATION: 186901869118692186931869418695 2003180718
3342411 122020000008 Germany ⤷  Try a Trial PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20110824
2269603 PA2015041 Lithuania ⤷  Try a Trial PRODUCT NAME: EVEROLIMUSUM; REGISTRATION NO/DATE: EU/1/09/538/001, EU/1/09/538/003, EU/1/09/538/004, EU/1/09/538/006-010 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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