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PACERONE

ANDA

AMIODARONE HYDROCHLORIDE | A075135 | UPSHER SMITH LABORATORIES LLC

3 strengths0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Pacerone (2023)

Total Spending

$6.4M

Total Claims

39,571

Beneficiaries

17,680

Avg Cost/Unit

$2.67

Spending Trend

$5.9M(2019)→$14.9M(2020)→$13.9M(2021)→$9.7M(2022)→$6.4M(2023)

YoY Change:-3.3%

5yr CAGR:+3.8%

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

API Supply Chain7 active DMFs5 inactive

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

PMC ISOCHEMAMIODARONE HYDROCHLORIDE

DMF 76171988

ALIVUS LIFE SCIENCES LTDAMIODARONE HYDROCHLORIDE USP

DMF 167872003

PIRAMAL PHARMA LTDAMIODARONE HYDROCHLORIDE

DMF 216942008

CTX LIFE SCIENCES PVT LTDAMIODARONE HYDROCHLORIDE USP

DMF 258922012

UNICHEM LABORATORIES LTDAMIODARONE HYDROCHLORIDE USP

DMF 336882019

HAINAN POLY PHARM CO LTDAMIODARONE HYDROCHLORIDE USP

DMF 361632021

EMCURE PHARMACEUTICALS LTDAMIODARONE HYDROCHLORIDE USP

DMF 381602023

SANOFI SYNTHELABO INCInactiveAMIODARONE HYDROCHLORIDE

DMF 49551983

LABORATOIRE CHOAYInactiveAMIODARONE HYDROCHLORIDE INJECTION

DMF 65291986

SHANGHAI SHENLONG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 141711999

AUROBINDO PHARMA LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 172172004

ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO LTDInactiveAMIODARONE HYDROCHLORIDE

DMF 245182010

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Feb 1, 2000	SUPPL -4	View Letter (PDF)
Dec 2, 1999	SUPPL -2	View Letter (PDF)
Sep 24, 1999	SUPPL -3	View Letter (PDF)
Apr 30, 1998	ORIG -1	View Letter (PDF)
Apr 30, 1998	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 200MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 30, 1998

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 12, 2005

#003 — 400MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 2, 2020