Viewing data from:

EVEROLIMUS

ANDA

EVEROLIMUS | A205775 | PH HEALTH LTD

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
49884028302EVEROLIMUS 1 MG TABLET	$6.76	EA	Generic	—	2026-06-17
49884016002EVEROLIMUS 0.75 MG TABLET	$5.19	EA	Generic	—	2026-06-17
49884015902EVEROLIMUS 0.5 MG TABLET	$3.69	EA	Generic	—	2026-06-17
49884015802EVEROLIMUS 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.

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
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 18, 2021

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2021

#003 — 0.75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2021

#004 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 18, 2021