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METHOTREXATE SODIUM

NDA

METHOTREXATE SODIUM | N008085 | STRIDES PHARMA INTERNATIONAL AG

1 strength0 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

Medicare Part D Spending

CMS annual spending data for Methotrexate Sodium (2023)

Total Spending

$843K

Total Claims

59,610

Beneficiaries

21,660

Avg Cost/Unit

$1.50

Spending Trend

$1.2M(2019)→$1.3M(2020)→$1.4M(2021)→$1.4M(2022)→$843K(2023)

YoY Change:-11.1%

5yr CAGR:-3.6%

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

API Supply Chain4 active DMFs2 inactive

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

EXCELLA GMBH AND CO KGMETHOTREXATE SODIUM

DMF 124721997

ALEMBIC PHARMACEUTICALS LTDMETHOTREXATE SODIUM

DMF 362772021

MSN LABORATORIES PRIVATE LTDMETHOTREXATE SODIUM

DMF 426272025

SHILPA PHARMA LIFESCIENCES LTDMETHOTREXATE SODIUM

DMF 427952025

BEN VENUE LABORATORIES INCInactiveMETHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED

DMF 61221985

LACHEMA BRNOInactiveMETHOTREXATE SODIUM

DMF 95261992

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 29, 2026	SUPPL -72	View Letter (PDF)
May 5, 2020	SUPPL -71	View Letter (PDF)
Mar 20, 2018	SUPPL -68	View Letter (PDF)
Feb 1, 2016	SUPPL -66	View Letter (PDF)
Jun 2, 2006	SUPPL -58	View Letter (PDF)
Nov 5, 2003	SUPPL -52	View Letter (PDF)
Nov 5, 2003	SUPPL -55	View Letter (PDF)
Feb 20, 2002	SUPPL -54	View Letter (PDF)
Feb 20, 2002	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.