Viewing data from:

CYSTADROPS

NDA

CYSTEAMINE HYDROCHLORIDE | N211302 | RECORDATI RARE DISEASES 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 Cystadrops (2023)

Total Spending

$2.3M

Total Claims

263

Beneficiaries

Avg Cost/Unit

$424.55

Spending Trend

$166K(2020)→$2.9M(2021)→$2.9M(2022)→$2.3M(2023)

YoY Change:+2.6%

5yr CAGR:+5.1%

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 20, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.37% BASE

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Aug 19, 2020

No patent or exclusivity listings for this strength.