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AFINITOR DISPERZ

NDA

EVEROLIMUS | N203985 | NOVARTIS PHARMACEUTICAL CORP

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Afinitor Disperz (2023)

Total Spending

$5.3M

Total Claims

151

Beneficiaries

Avg Cost/Unit

$690.12

Spending Trend

$6.1M(2019)→$9.6M(2020)→$8.6M(2021)→$6.4M(2022)→$5.3M(2023)

YoY Change:+14.7%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	SUPPL -28	View Letter (PDF)
May 6, 2024	SUPPL -27	View Letter (PDF)
Feb 2, 2022	SUPPL -23	View Letter (PDF)
Apr 19, 2021	SUPPL -20	View Letter (PDF)
Feb 14, 2020	SUPPL -16	View Letter (PDF)
Jan 23, 2020	SUPPL -17	View Letter (PDF)
Feb 1, 2016	SUPPL -10	View Letter (PDF)
Jan 26, 2015	SUPPL -8	View Letter (PDF)
Jul 3, 2014	SUPPL -7	View Letter (PDF)
Feb 21, 2014	SUPPL -5	View Letter (PDF)
Feb 21, 2014	SUPPL -4	View Letter (PDF)
Feb 21, 2014	SUPPL -2	View Letter (PDF)
Nov 7, 2013	SUPPL -3	View Letter (PDF)
Aug 31, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG

RLDAB

0 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 29, 2012

No patent or exclusivity listings for this strength.

#002 — 3MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 29, 2012

#003 — 5MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Aug 29, 2012