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ADEFOVIR DIPIVOXIL

ANDA

ADEFOVIR DIPIVOXIL | A202051 | SIGMAPHARM LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Medicare Part D Spending

CMS annual spending data for Adefovir Dipivoxil (2023)

Total Spending

$2.8M

Total Claims

2,797

Beneficiaries

418

Avg Cost/Unit

$25.22

Spending Trend

$4.8M(2019)→$4.1M(2020)→$3.7M(2021)→$3.4M(2022)→$2.8M(2023)

YoY Change:-4.7%

5yr CAGR:-2.5%

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

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE)

DMF 241512010

APOTEX INCADEFOVIR DIPIVOXIL

DMF 266302012

CIPLA LTDInactiveADEFOVIR DIPIVOXIL

DMF 201922007

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveADEFOVIR DIPIVOXIL

DMF 239932010

ALP PHARM BEIJING CO LTDInactiveADEFOVIR DIPIVOXIL

DMF 243362010

QILU PHARMACEUTICAL CO LTDInactiveADEFOVIR DIPIVOXIL (NON STERILE, API)

DMF 256412011

MYLAN LABORATORIES LTDInactiveADEFOVIR DIPIVOXIL

DMF 261172012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 3, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 29, 2013

No patent or exclusivity listings for this strength.