Viewing data from:

PEMETREXED DISODIUM

NDA

PEMETREXED DISODIUM | N214408 | ACCORD HEALTHCARE INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2025	SUPPL -5	View Letter (PDF)
Oct 16, 2023	SUPPL -3	View Letter (PDF)
Jul 21, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 19, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 19, 2022

#003 — EQ 850MG BASE/34ML (EQ 25MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 19, 2022

#004 — EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 19, 2022