Viewing data from:

EVEROLIMUS

ANDA

EVEROLIMUS | A214138 | ALKEM LABORATORIES LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AFINITOR(TE code: AB)

API Supply Chain17 active DMFs1 inactive

10 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

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.

Products (4)

Sort:

#001 — 0.25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 26, 2021

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 26, 2021

#003 — 0.75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 26, 2021

#004 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 26, 2021

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Alkem Labs' everolimus product (NDA 214138, Supplement 004) now carries a Risk Evaluation and Mitigation Strategy (REMS) requirement.

Old: No

New: Yes