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ZORTRESS

NDA

EVEROLIMUS | N021560 | NOVARTIS PHARMACEUTICALS CORP

4 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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Par Pharmaceutical Inc. 1:2014cv01289 3 patentseverolimus	D. Del.	2014-10-10	Terminated 2019-05-01	—
Novartis Pharmaceuticals Corporation et al v. West-Ward Pharmaceuticals International-Limited 1:2014cv01196 4 patentseverolimus	D. Del.	2014-09-16	Terminated 2019-03-14	—
Novartis Pharmaceuticals Corporation et al v. Breckenridge Pharmaceutical, Inc. 9:2014cv81067 4 patentseverolimus	S.D. Fla.	2014-08-15	Terminated 2014-10-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China NCT03736226	—	Active	Boston Scientific Corporation	2,000	2019-07-30 → 2028-03-31
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia NCT07270575	—	Not Yet Recruiting	Cardiovascular and Interventional Radiological Society of Europe	400	2026-08 → 2032-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Zortress (2023)

Total Spending

$2.0M

Total Claims

544

Beneficiaries

110

Avg Cost/Unit

$24.86

Spending Trend

$18.6M(2019)→$15.9M(2020)→$9.4M(2021)→$4.2M(2022)→$2.0M(2023)

YoY Change:-7.0%

5yr CAGR:+5.8%

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

13 letters from Drugs@FDA

Date	Submission	Document
Sep 15, 2023	SUPPL -33	View Letter (PDF)
Jun 13, 2023	SUPPL -31	View Letter (PDF)
Aug 12, 2020	SUPPL -22	View Letter (PDF)
Jan 17, 2018	SUPPL -20	View Letter (PDF)
Oct 14, 2016	SUPPL -19	View Letter (PDF)
Nov 9, 2015	SUPPL -18	View Letter (PDF)
Jan 28, 2015	SUPPL -11	View Letter (PDF)
Feb 20, 2013	SUPPL -6	View Letter (PDF)
Oct 4, 2012	SUPPL -8	View Letter (PDF)
May 4, 2012	SUPPL -9	View Letter (PDF)
Apr 27, 2012	SUPPL -7	View Letter (PDF)
Nov 28, 2011	SUPPL -4	View Letter (PDF)
Apr 29, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 20, 2010

No patent or exclusivity listings for this strength.

#002 — 0.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 2010

#003 — 0.75MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 20, 2010

#004 — 1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 10, 2018

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Novartis removed Zortress (everolimus) NDA 021560 from the Risk Evaluation and Mitigation Strategy (REMS) program.

Old: Yes

New: No