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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

378 trials from ClinicalTrials.gov — 15 recruiting, 9 active, 214 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia NCT00792948	Phase 2	Active	National Cancer Institute (NCI)	97	2009-09-01 → 2027-01-06
Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)NCT04127578	Phase 1/2	Active	Prevail Therapeutics	32	2020-01-03 → 2030-12-31
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant NCT02061800	Phase 1/2	Active	Diane George	14	2013-06-03 → 2026-07
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis NCT04305145	Phase 2	Active	Massachusetts General Hospital	42	2020-08-31 → 2030-06-30
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis NCT04221477	Phase 3	Active	Hoffmann-La Roche	271	2020-08-10 → 2031-03-02
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma NCT04270409	Phase 3	Active	Sanofi	337	2020-06-16 → 2033-10-21
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial NCT03875690	Phase 3	Active	Centre Hospitalier Universitaire Dijon	1,200	2019-07-02 → 2027-09
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma NCT02166463	Phase 3	Active	National Cancer Institute (NCI)	600	2015-03-19 → 2026-10-03
Post-operative Methylprednisolone Taper Course for Orthopedic Surgery NCT03661645	Phase 4	By Invitation	Emory University	500	2018-09-07 → 2029-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$10.96

per ml

Lowest NADAC/Unit

$7.08

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009347501DEPO-MEDROL 80 MG/ML VIAL	$10.96	ML	Brand	$11.80	2026-06-17
00009307301DEPO-MEDROL 40 MG/ML VIAL	$7.08	ML	Brand	$8.12	2026-06-17
00009307322DEPO-MEDROL 40 MG/ML VIAL	$7.08	ML	Brand	$8.12	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 22 NDCs (11 FSS, 11 Big4)

Lowest Price

$3.11

Highest Price

$1988.57

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-0274-01DEPO-MEDROL 20MG/ML INJ	$32.97	FSS	Pfizer Inc.	06/30/2029
00009-0274-01DEPO-MEDROL 20MG/ML INJ	$25.82	Big4	Pfizer Inc.	06/30/2029
00009-3073-01DEPO-MEDROL 40MG/ML INJ	$3.82	FSS	Pfizer Inc.	06/30/2029
00009-3073-01DEPO-MEDROL 40MG/ML INJ	$3.11	Big4	Pfizer Inc.	06/30/2029
00009-3073-03DEPO-MEDROL SAS	$138.19	FSS	Pfizer Inc.	06/30/2029
00009-3073-03DEPO-MEDROL SAS	$96.92	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 22 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Depo-Medrol (2024)

Total Spending

$25K

Total Claims

914

Beneficiaries

720

Avg Cost/Unit

$15.58

Spending Trend

$83K(2019)→$48K(2020)→$26K(2021)→$8K(2022)→$21K(2023)→$25K(2024)

YoY Change:+1.3%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Depo-Medrol (2024)

Total Spending

$10.3M

Total Claims

1,297,268

Beneficiaries

890,806

ASP Price

$0.13

HCPCS: J1010 — Injection, methylprednisolone acetate, 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

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