Viewing data from:

TREXALL

ANDA

METHOTREXATE SODIUM | A040385 | BARR LABORATORIES INC

4 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$48.21

per ea

Lowest NADAC/Unit

$24.09

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51285036801TREXALL 10 MG TABLET	$48.21	EA	—	—	2026-06-17
51285036701TREXALL 7.5 MG TABLET	$36.21	EA	—	—	2026-02-18
51285036601TREXALL 5 MG TABLET	$24.09	EA	—	—	2026-01-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

Medicare Part D Spending

CMS annual spending data for Trexall (2024)

Total Spending

$2.3M

Total Claims

7,121

Beneficiaries

1,987

Avg Cost/Unit

$41.74

Spending Trend

$1.3M(2019)→$1.6M(2020)→$1.6M(2021)→$2.0M(2022)→$2.1M(2023)→$2.3M(2024)

YoY Change:+5.6%

5yr CAGR:+7.4%

Source: CMS Medicare Part D Spending by Drug (2024). 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

1 letter from Drugs@FDA

Date	Submission	Document
Mar 21, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 21, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 7.5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2001

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2001

#004 — EQ 15MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2001