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PEMETREXED DISODIUM

ANDA

PEMETREXED DISODIUM | A203485 | ACCORD HEALTHCARE INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ALIMTA(TE code: AP)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
ELI LILLY AND COMPANY v. ACCORD HEALTHCARE INC., USA 1:2013cv00335 1 patentANDA 203485pemetrexed disodium	INSD	2013-02-28	Terminated 2013-06-24	—
ELI LILLY AND COMPANY v. ACCORD HEALTHCARE, INC., USA 1:2012cv00086 1 patentANDA 203485pemetrexed disodium	INSD	2012-01-20	Terminated 2017-08-11	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Medicare Part B Spending

CMS physician-administered drug spending for Pemetrexed Disodium (2023)

Total Spending

$82K

Total Claims

290

Beneficiaries

112

ASP Price

—

HCPCS: J9297 — Injection, pemetrexed (sandoz), not therapeutically equivalent to j9305, 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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.

Products (3)

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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 1GM BASE/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: May 25, 2022