Methylprednisolone

Controls severe or incapacitating allergic conditions. Sold as Medrol. Every FDA application for this active ingredient: 1 branded and 18 generic.

As of Nov 15, 2026, FDA lists 19 applications for Methylprednisolone (sold as Medrol), first approved Oct 24, 1957, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 24, 1957
Applications: 19
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $58.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Methylprednisolone	Part D	$43.5M	+4%	4,690,033
Depo-Medrol	Part B	$15.0M	+46%	1,332,132
Methylprednisolone Acetate	Part D	$223K	+1%	8,305
Depo-Medrol	Part D	$40K	+59%	1,284
Medrol	Part D	$10K	+7%	803
Medrol	Part B	$4K	-24%	78

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

METHYLPREDNISOLONE 16 MG TAB: $1.48 per unitGeneric · -9% in a year
METHYLPREDNISOLONE 32 MG TAB: $2.55 per unitGeneric · +1% in a year
METHYLPREDNISOLONE 4 MG DOSEPK: $0.144 per unitGeneric · +16% in a year
METHYLPREDNISOLONE 4 MG TABLET: $0.116 per unitGeneric · -21% in a year
METHYLPREDNISOLONE 40 MG/ML VL: $7.49 per MLGeneric · -8% in a year
METHYLPREDNISOLONE 400 MG/10 ML: $5.57 per MLGeneric · -3% in a year
METHYLPREDNISOLONE 8 MG TABLET: $0.923 per unitGeneric · -9% in a year
METHYLPREDNISOLONE 80 MG/ML VL: $11.92 per MLGeneric · +5% in a year
MEDROL 2 MG TABLET: $1.57 per unitBrand · new this year
MEDROL 4 MG DOSEPAK: $0.292 per unitBrand · +0% in a year
MEDROL 4 MG TABLET: $0.245 per unitBrand · new this year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Solu-MedrolDrugs with a new indication and a new dosage for the treatment of the acute phase of Kawasaki's disease (for patients with severe Kawasaki's disease who… · Pfizer Japan Inc. · Sep 25, 2023
Solu-MedrolDrugs with new additional indications and a new dosage for the treatment of the following treatment- resistant rheumatic diseases: systemic vasculitis… · Pfizer Japan Inc. · Aug 29, 2014
Solu-MedrolDrugs with a new additional indication and a new dosage for the treatment of acute exacerbation of multiple sclerosis. · Pfizer Japan Inc. · Mar 25, 2013
Solu-MedrolDrugs with a new additional indication and a new dosage for the treatment of nephrotic syndrome. · Fuji Pharma Co., Ltd. · May 20, 2011

Clinical Trials

457 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back PainChronic Low Back Pain, Lumbar Facet Syndrome · ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"	—	Not yet recruiting	Nov 10, 2026
Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Patients With Type 2 DiabetesChronic Low Back Pain, Type 2 Diabetes Mellitus (DM) · Hatice Zehra FERHATLAR	Not applicable	Recruiting	Nov 10, 2026
A Prospective, Open-label, Randomized, Multicenter Phase-III Trial to Evaluate the Efficacy of Pirtobrutinib and Epcoritamab Compared With R-(Mini)-CHOP for Treatment of Patients With DLBCL-type Richter TransformationRichter Transformation · German CLL Study Group	Phase 2	Recruiting	Nov 5, 2026
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital SchistosomiasisFemale Genital Schistosomiasis · Brian Ngwira	Phase 3	Not yet recruiting	Nov 4, 2026
MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)Metastatic Castration-resistant Prostate Cancer · Merck Sharp & Dohme LLC	Phase 1 / Phase 2	Not yet recruiting	Nov 2, 2026
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)Spinal Muscular Atrophy (SMA) · Exir Gene Pharmed	Early phase 1	Not yet recruiting	Oct 29, 2026
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff RepairShoulder · The Hawkins Foundation	Phase 4	Not yet recruiting	Oct 29, 2026
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical TrialAntibody-mediated Rejection, Antibody-Mediated Rejection (AMR) · First Affiliated Hospital, Sun Yat-Sen University	Phase 2	Active, not recruiting	Oct 29, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 24, 1957	MedrolNDA 11153 · New molecular entity	Pfizer	20	Marketed
Jul 28, 1981	MethylprednisoloneANDA 87341	Rising	0	Discontinued
Feb 9, 1982	MethylprednisoloneANDA 86159	Watson Labs	0	Discontinued
Feb 9, 1982	MethylprednisoloneANDA 86161	Watson Labs	1	Discontinued
Feb 21, 1984	MethylprednisoloneANDA 88497	Duramed Pharms Barr	29	Discontinued
Apr 25, 1988	MethylprednisoloneANDA 89207	Par Pharm	3	Discontinued
Apr 25, 1988	MethylprednisoloneANDA 89208	Par Pharm	3	Discontinued
Apr 25, 1988	MethylprednisoloneANDA 89209	Par Pharm	3	Discontinued
Oct 16, 1997	MethylprednisoloneANDA 40232	Watson Labs	1	Marketed
Oct 31, 1997	MethylprednisoloneANDA 40189	Jubilant Cadista	6	Marketed
Oct 31, 1997	MethylprednisoloneANDA 40194	Sandoz	11	Marketed
Dec 22, 1998	MethylprednisoloneANDA 40183	Ph Health	6	Marketed
Apr 23, 2018	MethylprednisoloneANDA 206751	Zydus Pharms	5	Marketed
May 14, 2018	MethylprednisoloneANDA 204072	Tianjin Tianyao	3	Marketed
Jan 9, 2019	MethylprednisoloneANDA 210985	Ingenus Pharms LLC	3	Discontinued
Feb 22, 2019	MethylprednisoloneANDA 209097	Chartwell Rx	1	Discontinued
Jun 27, 2019	MethylprednisoloneANDA 212262	Quagen	0	Discontinued
Sep 21, 2021	MethylprednisoloneANDA 207481	Amneal	1	Discontinued
—	MethylprednisoloneANDA 85650	Heather	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA