Viewing data from:

SOLU-MEDROL

NDA

METHYLPREDNISOLONE SODIUM SUCCINATE | N011856 | PHARMACIA AND UPJOHN CO

5 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

416 trials from ClinicalTrials.gov — 40 recruiting, 18 active, 216 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)NCT04548999	Phase 3	Active	Hoffmann-La Roche	769	2020-12-03 → 2027-09-08
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	352	2017-08-08 → 2027-08-14
Comparing Inotuzumab Combined With Low Intensity Chemotherapy Plus Blinatumomab to Usual Chemotherapy Plus Blinatumomab in Older Adults With CD22+ B-cell Acute Lymphoblastic Leukemia NCT05303792	Phase 2	Active	Alliance for Clinical Trials in Oncology	68	2023-06-09 → 2029-05
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
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
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis NCT04305145	Phase 2	Active	Massachusetts General Hospital	42	2020-08-31 → 2030-06-30
Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)NCT04408625	Phase 1/2	Active	Prevail Therapeutics	35	2020-11-09 → 2029-11-30
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy NCT04629248	Phase 3	Active	Hoffmann-La Roche	142	2021-06-25 → 2027-12-21
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors NCT06970743	Phase 3	Active	BeOne Medicines	153	2025-05-29 → 2029-11-30
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

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$10.05

per ea

Lowest NADAC/Unit

$6.28

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009004722SOLU-MEDROL 125 MG VIAL	$10.05	EA	Brand	—	2026-08-19
00009003928SOLU-MEDROL 40 MG VIAL	$6.28	EA	Brand	—	2026-08-19
00009003932SOLU-MEDROL 40 MG VIAL	$6.28	EA	Brand	—	2026-08-19
00009003906SOLU-MEDROL 40 MG VIAL	$6.28	EA	Brand	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$17.03

Highest Price

$194.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-0003-02SOLU-MEDROL PWD	$34.60	Big4	Pfizer Inc.	06/30/2029
00009-0003-02SOLU-MEDROL PWD	$47.07	FSS	Pfizer Inc.	06/30/2029
00009-0018-20SOLU-MEDROL 1GM INJ	$45.81	Big4	Pfizer Inc.	06/30/2029
00009-0018-20SOLU-MEDROL 1GM INJ	$57.48	FSS	Pfizer Inc.	06/30/2029
00009-0039-28SOLU-MEDROL STERILE POWDER	$96.74	Big4	Pfizer Inc.	06/30/2029
00009-0039-28SOLU-MEDROL STERILE POWDER	$122.36	FSS	Pfizer Inc.	06/30/2029

Showing 6 of 14 NDCs.

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

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Solu-Medrol — Methylprednisolone Sod Succ/PF (2024)

Total Spending

$330K

Total Claims

14,091

Beneficiaries

8,497

Avg Cost/Unit

$8.22

Spending Trend

$350K(2019)→$335K(2020)→$266K(2021)→$236K(2022)→$235K(2023)→$330K(2024)

YoY Change:+4.8%

5yr CAGR:+13.4%

Solu-Medrol — Methylprednisolone Sod Succ (2024)

Total Spending

$19K

Total Claims

227

Beneficiaries

109

Avg Cost/Unit

$10.59

Spending Trend

$55K(2019)→$58K(2020)→$56K(2021)→$35K(2022)→$30K(2023)→$19K(2024)

YoY Change:+167.8%

5yr CAGR:+38.0%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LUPIN LTDMETHYLPREDNISOLONE SODIUM SUCCINATE

DMF 303752016

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2025	SUPPL -143	View Letter (PDF)
Jun 7, 2024	SUPPL -144	View Letter (PDF)
Dec 22, 2023	SUPPL -141	View Letter (PDF)
May 28, 2021	SUPPL -136	View Letter (PDF)
Jul 26, 2018	SUPPL -133	View Letter (PDF)
Apr 1, 2018	SUPPL -131	View Letter (PDF)
Sep 9, 2016	SUPPL -126	View Letter (PDF)
Sep 9, 2016	SUPPL -124	View Letter (PDF)
Jul 7, 2014	SUPPL -123	View Letter (PDF)
Oct 25, 2011	SUPPL -103	View Letter (PDF)
Oct 25, 2011	SUPPL -104	View Letter (PDF)
Jun 28, 2010	SUPPL -107	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#003 — EQ 40MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#004 — EQ 125MG BASE/VIAL

RLDAP

0 patents0 exclusivities▾

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

#005 — EQ 500MG BASE/VIAL

RLDAP

0 patents0 exclusivities▾

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

#006 — EQ 1GM BASE/VIAL

RLDAP

0 patents0 exclusivities▾

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

#007 — EQ 2GM BASE/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 27, 1985