Viewing data from:

CUPRIMINE

NDA

PENICILLAMINE | N019853 | VALEANT PHARMACEUTICALS INTERNATIONAL

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 Cuprimine (2023)

Total Spending

$2.1M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$258.49

Spending Trend

$21.8M(2019)→$5.1M(2020)→$3.4M(2021)→$2.5M(2022)→$2.1M(2023)

YoY Change:-3.2%

5yr CAGR:+0.2%

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

API Supply Chain6 active DMFs3 inactive

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

BAUSCH HEALTH AMERICAS INCPENICILLAMINE USP

DMF 240132010

API PHARMA TECH LLCPENICILLAMINE USP

DMF 319322017

OPTIMUS DRUGS PRIVATE LTDPENICILLAMINE

DMF 324112018

NAVINTA LLCPENICILLAMINE USP

DMF 331062018

APITORIA PHARMA PRIVATE LTDPENICILLAMINE USP

DMF 332002018

MSN LIFE SCIENCES PRIVATE LTDPENICILLAMINE USP

DMF 344612019

BIOGAL PHARMACEUTICAL WORKSInactivePENICILLAMINE

DMF 54131984

BIOCHEMIE DEUTSCHLAND GMBHInactivePENICILLAMINE

DMF 136011998

WANBURY LTDInactivePENICILLAMINE

DMF 247012011

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 29, 2004	SUPPL -12	View Letter (PDF)
Oct 29, 2004	SUPPL -14	View Letter (PDF)
Nov 25, 2003	SUPPL -11	View Letter (PDF)
Nov 25, 2003	SUPPL -7	View Letter (PDF)
Jun 8, 2003	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 125MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982