Orange Book product · Generic (ANDA)
EVEROLIMUS
EVEROLIMUS
At a glance
Oct 30, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
EVEROLIMUS
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219955
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EVEROLIMUS
- 2012AFINITOR DISPERZBrand (NDA)
NDA 203985 · NOVARTIS PHARM
- 2010AFINITORBrand (NDA)
NDA 022334 · NOVARTIS
- 2010ZORTRESSBrand (NDA)
NDA 021560 · NOVARTIS
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 218488 · APOTEX
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 219533 · EUGIA PHARMA
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 217216 · BIOCON PHARMA
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 216140 · BIOCON PHARMA
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 217640 · NATCO
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 218863 · AMNEAL
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 214138 · ALKEM LABS LTD
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 205775 · PH HEALTH
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 205432 · BRECKENRIDGE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
