Viewing data from:

ZAVESCA

NDA

MIGLUSTAT | N021348 | ACTELION PHARMACEUTICALS US INC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Zavesca (2023)

Total Spending

$2.1M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$298.48

Spending Trend

$637K(2019)→$1.4M(2020)→$1.8M(2021)→$2.0M(2022)→$2.1M(2023)

YoY Change:-3.1%

5yr CAGR:-0.6%

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

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDMIGLUSTAT

DMF 262942013

DIPHARMA SAMIGLUSTAT

DMF 293292015

NAVINTA LLCMIGLUSTAT

DMF 364532021

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)MIGLUSTAT

DMF 418672025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2020	SUPPL -16	View Letter (PDF)
Jun 27, 2019	SUPPL -15	View Letter (PDF)
Feb 11, 2014	SUPPL -10	View Letter (PDF)
Nov 29, 2010	SUPPL -8	View Letter (PDF)
Mar 4, 2008	SUPPL -5	View Letter (PDF)
Aug 15, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 31, 2003

No patent or exclusivity listings for this strength.