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PEMETREXED

NDA

PEMETREXED DISODIUM | N215179 | SHILPA MEDICARE LTD

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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2035

Today

11147817

Mar. 26, 2035

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
EAGLE PHARMACEUTICALS, INC. et al v. SHIPLA MEDICARE LIMITED 2:2020cv20270 1 patentpemetrexed	D.N.J.	2020-12-23	Terminated 2021-04-19	—

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

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

2 letters from Drugs@FDA

Date	Submission	Document
Nov 19, 2024	SUPPL -2	View Letter (PDF)
May 23, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 100MG/10ML BASE (10MG/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 22, 2023

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11147817	Mar 26, 2035	—	—	Yes	—	—

#002 — EQ 500MG/50ML BASE (10MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 22, 2023

#003 — EQ 1GM/100ML BASE (10MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 22, 2023