Viewing data from:

EVEROLIMUS

ANDA

EVEROLIMUS | A207486 | HIKMA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AFINITOR(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$26.32

per ea

Lowest NADAC/Unit

$14.77

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054048213EVEROLIMUS 10 MG TABLET	$26.32	EA	Generic	—	2026-01-21
00054048113EVEROLIMUS 5 MG TABLET	$14.77	EA	Generic	—	2026-04-22

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$6647.48

Highest Price

$6647.48

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-0482-13EVEROLIMUS (ANTINEOPLASTIC) 10MG TAB	$6647.48	FSS	Golden State Medical Supply, Inc.	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain18 active DMFs1 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

CONCORD BIOTECH LTDEVEROLIMUS USP (WITH 2% BHT)

DMF 263502013

HANGZHOU HUADONG MEDICINE GROUP KANGRUN PHARMACEUTICAL CO LTDEVEROLIMUS

DMF 267382012

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDEVEROLIMUS PRE-MIX USP

DMF 268192013

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDEVEROLIMUS USP

DMF 272162013

CHENGDU YACHT BIO-TECHNOLOGY CO LTDEVEROLIMUS

DMF 294052015

BIOCON LTDEVEROLIMUS (WITH 0.2% BHT)

DMF 296512015

BIOCON LTDEVEROLIMUS

DMF 296572015

NATCO PHARMA LTDEVEROLIMUS

DMF 296962015

BIOCON LTDEVEROLIMUS (2% BHT)

DMF 319502018

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDEVEROLIMUS (NON-STERILE API)

DMF 320202017

CKD BIO CORPEVEROLIMUS, NON-STERILE API

DMF 341062019

FARMHISPANIA SAEVEROLIMUS (2.0% BHT)

DMF 342952019

BIOCON LTDEVEROLIMUS PREMIX 2%

DMF 356882021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDEVEROLIMUS (0.2%BHT)

DMF 366612021

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDEVEROLIMUS B02 USP

DMF 381112023

CHENGDU YACHT BIOTECHNOLOGY CO LTDEVEROLIMUS

DMF 393612024

MSN LABORATORIES PRIVATE LTDEVEROLIMUS USP

DMF 394122024

FARMHISPANIA SAEVEROLIMUS (2.0% BHT) USP-PROCESS II

DMF 423232025

SCINOPHARM TAIWAN LTDInactiveEVEROLIMUS

DMF 298542015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 6, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 8, 2020

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 8, 2020

#003 — 7.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 8, 2020

#004 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 23, 2021