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FDA Orange Book · active-ingredient family

Everolimus

Everolimus is approved as 3 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AFINITOR DISPERZ · NDA 203985

3

Brand (NDA)

18

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, for suspension

ProductApplicantApplicationTEApproved
AFINITOR DISPERZRLD×3NOVARTIS PHARMNDA 203985ABAug 29, 2012
AFINITORRLD×4NOVARTISNDA 022334ABJul 09, 2010
ZORTRESSRLD×4NOVARTISNDA 021560ABApr 20, 2010

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
EVEROLIMUS×4APOTEXANDA 218488ABMay 12, 2026
EVEROLIMUS×4EUGIA PHARMAANDA 219533ABFeb 25, 2026
EVEROLIMUS×3BIOCON PHARMAANDA 217216ABJan 09, 2026
EVEROLIMUS×4NOVUGENANDA 219955ABOct 30, 2025
EVEROLIMUS×4BIOCON PHARMAANDA 216140ABApr 09, 2025
EVEROLIMUS×3NATCOANDA 217640ABJan 28, 2025
EVEROLIMUS×3AMNEALANDA 218863ABJan 10, 2025
EVEROLIMUS×4ALKEM LABS LTDANDA 214138ABNov 26, 2021
EVEROLIMUS×4PH HEALTHANDA 205775ABOct 18, 2021
EVEROLIMUS×4BRECKENRIDGEANDA 205432ABMay 20, 2021
EVEROLIMUS×4BRECKENRIDGEANDA 205426ABMar 05, 2021
EVEROLIMUS×4BIOCON PHARMAANDA 214182ABFeb 11, 2021
EVEROLIMUS×4HIKMAANDA 207486ABJun 08, 2020
EVEROLIMUS×4MYLANANDA 212936—Jun 08, 2020
EVEROLIMUS×4PH HEALTHANDA 207934—Dec 09, 2019
EVEROLIMUS×4TEVA PHARMS USAANDA 210050ABDec 09, 2019
EVEROLIMUS×3MYLANANDA 210130—Apr 19, 2019
EVEROLIMUS×4HIKMAANDA 206133ABApr 12, 2018

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8410131Nov 01, 20258 mo ago
U-1368
8410131*PEDMay 01, 20262 mo ago
9006224Jul 01, 2028in 2 yr 1 mo
U-1681

Everolimus — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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