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Last Updated: May 28, 2022

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

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

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
Mylan EVEROLIMUS everolimus TABLET, FOR SUSPENSION;ORAL 210130-003 Apr 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis AFINITOR everolimus TABLET;ORAL 022334-003 Jul 9, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hikma EVEROLIMUS everolimus TABLET;ORAL 206133-002 Apr 12, 2018 AB RX No No See Plans and Pricing See Plans and Pricing 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for everolimus

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2269603 300769 Netherlands See Plans and Pricing 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 300849 Netherlands See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246 C03351246/01 Switzerland See Plans and Pricing PRODUCT NAME: EVEROLIMUS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 59174 27.02.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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