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CYSTARAN

NDA

CYSTEAMINE HYDROCHLORIDE | N200740 | LEADIANT BIOSCIENCES 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
European Cystinosis Cohort 2 NCT07680751	—	Not Yet Recruiting	Institut National de la Santé Et de la Recherche Médicale, France	250	2026-07-01 → 2028-03-01

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

Medicare Part D Spending

CMS annual spending data for Cystaran (2023)

Total Spending

$2.0M

Total Claims

233

Beneficiaries

Avg Cost/Unit

$144.95

Spending Trend

$3.1M(2019)→$2.4M(2020)→$956K(2022)→$2.0M(2023)

YoY Change:+20.0%

5yr CAGR:+7.5%

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

API Supply Chain3 active DMFs

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPACYSTEAMINE HYDROCHLORIDE

DMF 329112019

ACIC PHARMACEUTICALS INCCYSTEAMINE HYDROCHLORIDE

DMF 369072022

GLAND PHARMA LTDCYSTEAMINE HYDROCHLORIDE

DMF 374152022

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 28, 2022	SUPPL -3	View Letter (PDF)
Apr 28, 2020	SUPPL -1	View Letter (PDF)
Oct 4, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.44% BASE

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 2, 2012

No patent or exclusivity listings for this strength.