Viewing data from:

SOLU-CORTEF

NDA

HYDROCORTISONE SODIUM SUCCINATE | N009866 | PHARMACIA AND UPJOHN CO

4 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-Cortef (2023)

Total Spending

$674K

Total Claims

9,502

Beneficiaries

5,401

Avg Cost/Unit

$9.39

Spending Trend

$103K(2019)→$458K(2019)→$133K(2020)→$541K(2020)→$112K(2021)→$623K(2021)→$716K(2022)→$135K(2022)→$119K(2023)→$674K(2023)

YoY Change:+10.2%

5yr CAGR:+6.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Solu-Cortef (2023)

Total Spending

$441K

Total Claims

24,445

Beneficiaries

8,291

ASP Price

—

HCPCS: J1720 — Injection, hydrocortisone sodium succinate, up to 100 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain1 active DMF1 inactive

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

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE SODIUM SUCCINATE

DMF 423422025

DIOSYNTH BVInactiveHYDROCORTISONE SODIUM SUCCINATE

DMF 41221981

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jul 18, 2024	SUPPL -120	View Letter (PDF)
Jun 7, 2024	SUPPL -121	View Letter (PDF)
Dec 22, 2023	SUPPL -119	View Letter (PDF)
May 28, 2021	SUPPL -115	View Letter (PDF)
Nov 22, 2019	SUPPL -113	View Letter (PDF)
Sep 9, 2016	SUPPL -105	View Letter (PDF)
Sep 9, 2016	SUPPL -98	View Letter (PDF)
Jul 8, 2014	SUPPL -104	View Letter (PDF)
Jun 28, 2010	SUPPL -80	View Letter (PDF)
Nov 9, 2009	SUPPL -77	View Letter (PDF)
Nov 9, 2009	SUPPL -79	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 100MG BASE/VIAL

RLDAP

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 250MG BASE/VIAL

RLD

0 patents0 exclusivities▾

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

#003 — EQ 500MG BASE/VIAL

RLD

0 patents0 exclusivities▾

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

#004 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▾

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