Viewing data from:

EVEROLIMUS

ANDA

EVEROLIMUS | A206133 | 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 | 4 NDCs

Highest NADAC/Unit

$6.76

per ea

Lowest NADAC/Unit

$2.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00054060421EVEROLIMUS 1 MG TABLET	$6.76	EA	Generic	—	2026-06-17
00054047221EVEROLIMUS 0.75 MG TABLET	$5.19	EA	Generic	—	2026-06-17
00054047121EVEROLIMUS 0.5 MG TABLET	$3.69	EA	Generic	—	2026-06-17
00054047021EVEROLIMUS 0.25 MG TABLET	$2.12	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$372.40

Highest Price

$1472.09

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00054-0470-21EVEROLIMUS (IMMUNOSUPPRESSIVE) 0.25MG TAB	$372.40	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0604-21EVEROLIMUS (IMMUNOSUPPRESSIVE) 1MG TAB	$1472.09	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0471-21EVEROLIMUS (IMMUNOSUPPRESSIVE) 0.5MG TAB	$780.73	FSS	Golden State Medical Supply, Inc.	06/14/2028
00054-0472-21EVEROLIMUS (IMMUNOSUPPRESSIVE) 0.75MG TAB	$1166.07	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
May 11, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 12, 2018

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 12, 2018

#003 — 0.75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 12, 2018

#004 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 18, 2021