Orange Book product · Brand (NDA)

AFINITOR

EVEROLIMUS

Brand (NDA)NDA 022334TE ABRX NOVARTIS

Jul 09, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 09, 2010
16 yr 2 mo ago
Patent 8410131 expires
Listed method-of-use patent (U-1368) expiration.
Nov 01, 2025
8 mo ago
Patent 8410131*PED expires
Listed listed patent expiration.
May 01, 2026
2 mo ago
Today
Patent 9006224 expires
Listed method-of-use patent (U-1681) expiration.
Jul 01, 2028
in 2 yr 1 mo

Active ingredient

EVEROLIMUS

Strength

2.5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022334

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8410131	Nov 01, 2025	8 mo ago	U-1368
8410131*PED	May 01, 2026	2 mo ago
9006224	Jul 01, 2028	in 2 yr 1 mo	U-1681