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NDA

MIDAZOLAM HYDROCHLORIDE | N018654 | HLR TECHNOLOGY

2 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

6 trials from ClinicalTrials.gov — 4 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years NCT07670377	Phase 1	Not Yet Recruiting	GlaxoSmithKline	20	2026-06-26 → 2026-08-31
A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma NCT07660731	Phase 1	Recruiting	Pfizer	139	2026-06-17 → 2027-06-18
Ketamine for Combined Depression and Alcohol Use Disorder NCT06090422	Phase 1/2	Recruiting	University Hospital of North Norway	34	2025-01-20 → 2027-07-01
Induction in the Dark NCT06144177	Phase 4	Recruiting	Medical University of South Carolina	240	2024-04-16 → 2027-05-22
A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants NCT06679413	Phase 1	Completed	UCB BIOSCIENCES, Inc.	22	2024-12-04 → 2025-06-12
Amobarbital and Cardiopulmonary Bypass NCT06757868	N/A	Completed	Tongji Hospital	80	2025-02-01 → 2026-04-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF

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

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM HYDROCHLORIDE

DMF 399912024

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

Products (2)

Sort:

#001 — EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 20, 1985

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 26, 1987