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Last Updated: February 28, 2021

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When do Everolimus patents expire, and what generic alternatives are available?

Everolimus is a drug marketed by Mylan, Hikma, Par Pharm, and Teva Pharms Usa. and is included in six NDAs.

The generic ingredient in EVEROLIMUS is everolimus. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the everolimus profile page.

US ANDA Litigation and Generic Entry Outlook for Everolimus

A generic version of EVEROLIMUS was approved as everolimus by HIKMA on April 12th, 2018.

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Drug patent expirations by year for EVEROLIMUS
Drug Prices for EVEROLIMUS

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Recent Clinical Trials for EVEROLIMUS

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

The Hospital for Sick ChildrenN/A
Fondazione per la Medicina PersonalizzataPhase 2
National Cancer Institute, FrancePhase 2

See all EVEROLIMUS clinical trials

Medical Subject Heading (MeSH) Categories for EVEROLIMUS
Paragraph IV (Patent) Challenges for EVEROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
AFINITOR TABLET;ORAL everolimus 022334 2014-12-10
AFINITOR TABLET;ORAL everolimus 022334 2014-06-18
ZORTRESS TABLET;ORAL everolimus 021560 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 210130-001 Apr 19, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa EVEROLIMUS everolimus TABLET;ORAL 210050-001 Dec 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma EVEROLIMUS everolimus TABLET;ORAL 207486-001 Jun 8, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma EVEROLIMUS everolimus TABLET;ORAL 206133-001 Apr 12, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan EVEROLIMUS everolimus TABLET;ORAL 212936-003 Jun 8, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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