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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Mapi USA, Inc FDA-2018-P-1678 · 6 docket documents Mapi USA, Inc. filed this citizen petition under section 505(j)(2)(C) and 21 C.F.R. §314.93 requesting FDA permission to submit an ANDA for Midazolam Injection USP 1 mg/mL in a new 100 mL flexible plastic container presentation for intravenous use in intensive care settings, differing from the refer	Other	2018-05-01	Denied	Mapi USA, Inc

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

Clinical Trials

450 trials from ClinicalTrials.gov — 5 recruiting, 6 active, 333 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer NCT02365597	Phase 2	Active	Janssen Research & Development, LLC	239	2015-04-22 → 2027-03-31
Understanding How Ketamine Brings About Rapid Improvement in OCD NCT02624596	Phase 2	Active	Stanford University	120	2016-06 → 2026-06
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability NCT02078336	Phase 4	Active	Universitaire Ziekenhuizen KU Leuven	40	2013-12 → 2025-07
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia NCT04067336	Phase 1/2	Active	Kura Oncology, Inc.	263	2019-09-12 → 2028-10-16
Safety of Driving After Minor Surgery With Monitored Anesthesia Care NCT00577200	Phase 4	Active	Rush University Medical Center	625	2008-01 → 2026-12
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer NCT03436485	Phase 1/2	Active	Orion Corporation, Orion Pharma	204	2018-03-19 → 2026-07-31
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients NCT03401593	N/A	Not Yet Recruiting	Yonsei University	135	2019-10 → 2028-06
Quelling of Excitotoxicity in Acute Stroke With Ketamine NCT03223220	Phase 2/3	Not Yet Recruiting	Lower Merion Neurology Research Foundation	120	2024-07-01 → 2027-12-31
The Effects of Different Anesthetics on Functional Connectivity NCT03343873	N/A	Recruiting	Beijing Tiantan Hospital	240	2017-04-01 → 2025-12-31
Sedation Versus Protective Stabilization for Pediatric Dental Treatment NCT04119180	Phase 4	Recruiting	Universidade Federal de Goias	152	2020-01-30 → 2026-02-28

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