Midazolam Patent Expiration

Midazolam was first introduced by Ucb Inc in its drug Nayzilam on May 17, 2019. Other drugs containing Midazolam are Midazolam In 0.9% Sodium Chloride, Midazolam In 0.8% Sodium Chloride. 6 different companies have introduced drugs containing Midazolam.


Midazolam Patents

Given below is the list of patents protecting Midazolam, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Midazolam In 0.9% Sodium Chloride US10966990 Midazolam in flexible bags Jun 20, 2038 Inforlife
Nayzilam US8217033 Methods and compositions for the delivery of a therapeutic agent Jan 18, 2028 Ucb Inc
Nayzilam US8809322 Methods and compositions for the delivery of a therapeutic agent Jan 18, 2028 Ucb Inc
Nayzilam US9289432 Methods and compositions for the delivery of a therapeutic agent Jan 18, 2028 Ucb Inc
Nayzilam US9687495 Methods and systems for the delivery of a therapeutic agent Jan 18, 2028 Ucb Inc



Midazolam's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Midazolam:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Murdoch Childrens Research Institute NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children Vanderbilt University Medical Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Intraoperative Midazolam on Delirium Outcome of Elderly Patients Chinese PLA General Hospital NA COMPLETED
(Sep 1, 2026)
PHASE1
Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery Cairo University NA COMPLETED
(Sep 1, 2026)
PHASE2
An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of LY4355756 in Healthy Participants Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Understanding How Ketamine Brings About Rapid Improvement in OCD Stanford University NA COMPLETED
(Aug 1, 2026)
PHASE2
Enhancing Week-long Psychological Treatment for PTSD With Ketamine Yale University NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women Boehringer Ingelheim NA SUSPENDED
(Aug 1, 2026)
PHASE1
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
Dexmedetomidine for Invasive Ventilation In the NEOnate Centre Hospitalier Intercommunal Creteil NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
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 Pfizer NA RECRUITING
(Aug 1, 2026)
PHASE1
A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight Novo Nordisk A/S NA RECRUITING
(Aug 1, 2026)
PHASE1
Ketamine-enhanced Prolonged Exposure Therapy in PTSD VA Office of Research and Development NA COMPLETED
(Jul 1, 2026)
PHASE2
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia University Hospital, Montpellier NA RECRUITING
(Jul 1, 2026)
PHASE3
Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone Sparrow Pharmaceuticals NA COMPLETED
(Jul 1, 2026)
PHASE1
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants ViiV Healthcare NA RECRUITING
(Jul 1, 2026)
PHASE1
Drug-Interaction Assessment of GSK3772701 in Healthy Male and Female Participants Aged 18 to 55 Years GlaxoSmithKline NA RECRUITING
(Jul 1, 2026)
PHASE1
A Drug-Drug Interaction Study Between NTQ5082 Capsules and Midazolam Oral Solutio The Third Xiangya Hospital of Central South University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation Centre Hospitalier Universitaire, Amiens NA COMPLETED
(Jun 1, 2026)
PHASE3
A Study of LY3502970 in Healthy Participants Eli Lilly and Company NA COMPLETED
(Jun 1, 2026)
PHASE1
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors Cogent Biosciences, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE3
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People Boehringer Ingelheim NA TERMINATED
(Jun 1, 2026)
PHASE1
An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer Jiangsu Hansoh Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Turning Point Therapeutics, Inc. NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Ketamine for Multiple Sclerosis Fatigue Johns Hopkins University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Phase 1, First-in-human Study of VX-433 Vertex Pharmaceuticals Incorporated NA RECRUITING
(May 1, 2026)
PHASE1
KetAmine and Recovery After Mechanical VentilAtion ( KARMA ) Assistance Publique - Hôpitaux de Paris NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Sedation vs No Sedation in Mechanically Ventilated COPD Patients Al-Azhar University NA COMPLETED
(May 1, 2026)
PHASE2
Ketamine for Combined Depression and Alcohol Use Disorder University Hospital of North Norway NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates Sanofi NA COMPLETED
(Apr 1, 2026)
PHASE1
A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants Eli Lilly and Company NA COMPLETED
(Apr 1, 2026)
PHASE1
Nebulized Ketamine for the Treatment of Major Depressive Disorder Theresa Jacob, PhD, MPH NA RECRUITING
(Apr 1, 2026)
PHASE3
The Effects of Remimazolam on Cerebral Blood Flow Following General Anesthesia Induction Jun Zhang NA COMPLETED
(Apr 1, 2026)
PHASE3
The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients Ain Shams University NA RECRUITING
(Apr 1, 2026)
PHASE2
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care University Hospital, Tours NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants UCB BIOSCIENCES, Inc. NA COMPLETED
(Mar 1, 2026)
PHASE1
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. PMV Pharmaceuticals, Inc NA RECRUITING
(Mar 1, 2026)
PHASE1


Midazolam Generic API Manufacturers

Several generic applications have been filed for Midazolam. The first generic version for Midazolam was by Hikma Pharmaceuticals Usa Inc and was approved on Apr 17, 2023. And the latest generic version is by B Braun Medical Inc and was approved on May 1, 2025.

Given below is the list of companies who have filed for Midazolam generic, along with the locations of their manufacturing plants worldwide.