Viewing data from:

CYSTAGON

NDA

CYSTEAMINE BITARTRATE | N020392 | MYLAN PHARMACEUTICALS INC

2 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

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 Cystagon (2023)

Total Spending

$75K

Total Claims

141

Beneficiaries

Avg Cost/Unit

$0.92

Spending Trend

$66K(2019)→$65K(2020)→$55K(2021)→$60K(2022)→$75K(2023)

YoY Change:+7.0%

5yr CAGR:+5.3%

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

API Supply Chain7 active DMFs

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

CAMBREX PROFARMACO MILANO SRLCYSTEAMINE BITARTRATE

DMF 96191992

ACIC PHARMACEUTICALS INCCYSTEAMINE BITARTRATE

DMF 268162013

CAMBREX PROFARMACO MILANO SRLCYSTEAMINE BITARTRATE (RP)

DMF 275742013

LUPIN MANUFACTURING SOLUTIONS LTDCYSTEAMINE BITARTRATE

DMF 326682018

MAITHRI LABORATORIES PRIVATE LTDCYSTEAMINE BITARTRATE (MONOHYDRATE)

DMF 357582021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCYSTEAMINE BITARTRATE

DMF 370942022

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPACYSTEAMINE BITARTRATE

DMF 382092023

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2007	SUPPL -10	View Letter (PDF)
Feb 3, 2004	SUPPL -7	View Letter (PDF)
Apr 11, 2001	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 50MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 15, 1994

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 15, 1994