Viewing data from:

DEPO-MEDROL

NDA

METHYLPREDNISOLONE ACETATE | N011757 | PFIZER INC

3 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

Medicare Part D Spending

CMS annual spending data for Depo-Medrol (2023)

Total Spending

$21K

Total Claims

704

Beneficiaries

604

Avg Cost/Unit

$15.37

Spending Trend

$83K(2019)→$48K(2020)→$26K(2021)→$8K(2022)→$21K(2023)

YoY Change:-7.4%

5yr CAGR:+1.3%

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

API Supply Chain7 active DMFs3 inactive

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

EUROAPI FRANCEMETHYLPREDNISOLONE ACETATE

DMF 34521979

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCMETHYLPREDNISOLONE ACETATE USP

DMF 48131983

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMETHYLPREDNISOLONE ACETATE (BULK) USP

DMF 189562006

CURIA SPAIN SAUMETHYLPREDNISOLONE ACETATE STERILE MICRONIZED

DMF 238202010

SYMBIOTEC PHARMALAB PRIVATE LTDMETHYLPREDNISOLONE ACETATE USP

DMF 246112011

FARMABIOS SPAMETHYLPREDNISOLONE ACETATE STERILE

DMF 273252013

HIKMA PHARMACEUTICALS PLCMETHYLPREDNISOLONE ACETATE USP (STERILE)

DMF 307892016

DIOSYNTH BVInactiveMETHYLPREDNISOLONE ACETATE

DMF 35961979

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveMETHYLPREDNISOLONE ACETATE

DMF 46341982

QUATRUMInactiveMETHYLPREDNISOLONE ACETATE

DMF 68881987

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2025	SUPPL -124	View Letter (PDF)
Jun 7, 2024	SUPPL -125	View Letter (PDF)
Dec 22, 2023	SUPPL -123	View Letter (PDF)
May 28, 2021	SUPPL -120	View Letter (PDF)
Feb 16, 2021	SUPPL -119	View Letter (PDF)
Jul 26, 2018	SUPPL -114	View Letter (PDF)
Mar 20, 2017	SUPPL -111	View Letter (PDF)
Sep 9, 2016	SUPPL -104	View Letter (PDF)
Jul 8, 2014	SUPPL -103	View Letter (PDF)
Apr 16, 2009	SUPPL -86	View Letter (PDF)
Apr 16, 2009	SUPPL -85	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG/ML

RLDAB

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 20MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 80MG/ML

RLDAB

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982