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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Solu-Medrol (2023)

Total Spending

$30K

Total Claims

365

Beneficiaries

145

Avg Cost/Unit

$3.95

Spending Trend

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

YoY Change:+21.8%

5yr CAGR:+13.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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