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Last Updated: May 26, 2022

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 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
Genentech, Inc.Phase 3
Karolinska University HospitalPhase 3
Skane University HospitalPhase 3

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
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-001 Mar 30, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-004 Mar 30, 2012 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EVEROLIMUS

Country Patent Number Title Estimated Expiration
Czech Republic 303611 Farmaceutické prostredky s obsahem derivátu rapamycinu pro lécení solidních nádoru (Pharmaceutical compositions containing rapamycin derivative and intended for treating solid tumors) See Plans and Pricing
Russian Federation 2487711 ЛЕЧЕНИЕ НЕЙРОЭНДОКРИННЫХ ОПУХОЛЕЙ (TREATING NEUROENDOCRINE TUMOURS) See Plans and Pricing
Russian Federation 2006140514 See Plans and Pricing
Cyprus 1116616 See Plans and Pricing
Czech Republic 2010473 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EVEROLIMUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3143995 LUC00122 Luxembourg See Plans and Pricing PRODUCT NAME: EVEROLIMUS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001, 003, 004, 006-010 20160530
2269604 122016000094 Germany See Plans and Pricing PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
3143995 2019C/528 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), FUSION
0663916 C00663916/01 Switzerland See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 56238 21.04.2005
2269604 62/2016 Austria See Plans and Pricing PRODUCT NAME: EVEROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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