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

297 trials from ClinicalTrials.gov — 7 recruiting, 13 active, 194 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 NCT03286634	Phase 2	Active	National Hospital Organization Nagoya Medical Center	60	2017-04-18 → 2033-03-31
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer NCT00859781	Phase 2	Active	Weill Medical College of Cornell University	55	2009-06 → 2026-09
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia NCT02101853	Phase 3	Active	National Cancer Institute (NCI)	669	2014-12-17 → 2026-09-16
Hormonal Mechanisms of Sleep Restriction - Axis Study NCT03142893	Phase 1	Active	Peter y. Liu	80	2017-05-08 → 2026-06-30
Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)NCT04082533	Phase 4	Active	Hospital for Special Surgery, New York	132	2019-07-24 → 2026-05
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications NCT02775227	Phase 4	Active	Helsinki University Central Hospital	126	2016-05 → 2029-12
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I NCT02553460	Phase 1/2	Active	St. Jude Children's Research Hospital	50	2016-01-29 → 2031-10
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women NCT04037605	Early Phase 1	Active	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	5	2020-02-09 → 2026-06-24
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
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

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

$51.43

per ea

Lowest NADAC/Unit

$20.48

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009001305SOLU-CORTEF 250 MG ACT-O-VIAL	$51.43	EA	Brand	—	2026-07-01
00009001104SOLU-CORTEF 100 MG ACT-O-VIAL	$24.68	EA	Brand	—	2026-07-01
00009082501SOLU-CORTEF 100 MG VIAL	$20.48	EA	Brand	$15.13	2026-07-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$10.53

Highest Price

$995.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00009-0005-01SOLU-CORTEF 1GM ACT-O-VIAL	$159.35	FSS	Pfizer Inc.	06/30/2029
00009-0005-01SOLU-CORTEF 1GM ACT-O-VIAL	$119.44	Big4	Pfizer Inc.	06/30/2029
00009-0013-05SOLU-CORTEF 250MG ACT-O-VIAL	$39.37	FSS	Pfizer Inc.	06/30/2029
00009-0013-05SOLU-CORTEF 250MG ACT-O-VIAL	$28.43	Big4	Pfizer Inc.	06/30/2029
00009-0013-06SOLU-CORTEF 125MG/ML INJ	$995.81	FSS	Pfizer Inc.	06/30/2029
00009-0013-06SOLU-CORTEF 125MG/ML INJ	$771.16	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 12 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-Cortef — Hydrocortisone Sodium Succ/PF (2024)

Total Spending

$990K

Total Claims

13,384

Beneficiaries

7,708

Avg Cost/Unit

$13.83

Spending Trend

$458K(2019)→$541K(2020)→$623K(2021)→$716K(2022)→$674K(2023)→$990K(2024)

YoY Change:+47.2%

5yr CAGR:+13.8%

Solu-Cortef — Hydrocortisone Sod Succinate (2024)

Total Spending

$123K

Total Claims

1,790

Beneficiaries

1,221

Avg Cost/Unit

$12.02

Spending Trend

$103K(2019)→$133K(2020)→$112K(2021)→$135K(2022)→$119K(2023)→$123K(2024)

YoY Change:+11.4%

5yr CAGR:-3.3%

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 Solu-Cortef (2024)

Total Spending

$480K

Total Claims

24,926

Beneficiaries

7,252

ASP Price

$18.89

Spending Trend

$597K(2019)→$591K(2020)→$642K(2021)→$680K(2022)→$441K(2023)→$480K(2024)

YoY Change:+6.8%

5yr CAGR:+8.3%

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

Source: CMS Medicare Part B Spending by Drug (2024). 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