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PENICILLAMINE

ANDA

PENICILLAMINE | A210976 | WATSON LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CUPRIMINE(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Penicillamine (2023)

Total Spending

$10.1M

Total Claims

1,042

Beneficiaries

162

Avg Cost/Unit

$84.65

Spending Trend

$3.6M(2019)→$9.1M(2020)→$9.8M(2021)→$10.7M(2022)→$10.1M(2023)

YoY Change:-10.9%

5yr CAGR:-18.7%

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 5, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 24, 2019

No patent or exclusivity listings for this strength.