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HYDROCORTONE

NDA

HYDROCORTISONE SODIUM PHOSPHATE | N012052 | MERCK AND CO INC

1 strength0 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps, & McNamara, P.C. FDA-2021-P-0940 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether HYDROCORTONE (Hydrocortisone sodium phosphate) Injection EQ 50mg base/mL, approved under NDA 012052 and held by Merck and Co Inc, was withdrawn from the market for safety or effectiveness reasons. The petiti	505(q)	2021-08-26	Granted	Hyman, Phelps, & McNamara, P.C.
Citizen Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-1991 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Hydrocortone (hydrocortisone sodium phosphate) Injection, 50 mg base/mL, approved under NDA 012052 and held by Merck	505(q)	2020-09-21	Granted	HYMAN, PHELPS & MCNAMARA, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

API Supply Chain1 active DMF2 inactive

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

CURIA SPAIN SAUHYDROCORTISONE SODIUM PHOSPHATE

DMF 359572021

DIOSYNTH BVInactiveHYDROCORTISONE SODIUM PHOSPHATE

DMF 40261981

ROUSSELL UCLAFInactiveHYDROCORTISONE SODIUM PHOSPHATE

DMF 74161988

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

Products (1)

#001 — EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.