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PEMETREXED DISODIUM

ANDA

PEMETREXED DISODIUM | A090384 | FRESENIUS KABI USA LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ALIMTA(TE code: AP)

Medicare Part D Spending

CMS annual spending data for Pemetrexed Disodium (2023)

Total Spending

$2.6M

Total Claims

1,498

Beneficiaries

347

Avg Cost/Unit

$590.61

Spending Trend

$1.7M(2022)→$2.6M(2023)

YoY Change:-30.6%

5yr CAGR:-30.6%

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

API Supply Chain12 active DMFs2 inactive

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

SHANDONG ANHONG PHARMACEUTICAL CO LTDPEMETREXED DISODIUM

DMF 233412009

CHEMWERTH INCPEMETREXED DISODIUM

DMF 234172009

DR REDDYS LABORATORIES LTDPEMETREXED DISODIUM (AMORPHOUS)

DMF 243882010

SHILPA PHARMA LIFESCIENCES LTDPEMETREXED DISODIUM (HEMIPENTA HYDRATE)

DMF 251022011

RELIANCE LIFE SCIENCES PVT LTDPEMETREXED DISODIUM

DMF 255592012

SUZHOU LIXIN PHARMACEUTICAL CO LTDPEMETREXED DISODIUM (NON STERILE)

DMF 256402011

LAURUS LABS LTDPEMETREXED DISODIUM

DMF 264312012

SUN PHARMACEUTICAL INDUSTRIES LTDPEMETREXED DISODIUM USP

DMF 266142012

SCINOPHARM TAIWAN LTDPEMETREXED DISODIUM USP

DMF 339502019

DR REDDYS LABORATORIES LTDPEMETREXED DISODIUM USP (HEPTAHYDRATE)

DMF 347542020

CHONGQING CARELIFE PHARMACEUTICAL CO LTDPEMETREXED DISODIUM

DMF 359892021

RAVI BIOLIFE PRIVATE LTDPEMETREXED DISODIUM USP

DMF 395232024

NEULAND LABORATORIES LTDInactivePEMETREXED DISODIUM (FORM IV)

DMF 256182011

ITF CHEMICAL LTDAInactivePEMETREXED DISODIUM EP

DMF 292862015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 26, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 100MG BASE/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: May 25, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: May 25, 2022

#003 — EQ 750MG BASE/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: May 25, 2022

#004 — EQ 1GM BASE/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: May 25, 2022