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 0.8% Sodium Chloride, Midazolam In 0.9% Sodium Chloride. 5 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.

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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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 Gland Pharma Ltd and was approved on Aug 12, 2024.

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


1. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 2 different strengths of generic version for Midazolam. All of these versions come by the name MIDAZOLAM IN 0.9% SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/50ML (1MG/ML)

solution Prescription INTRAVENOUS AP Aug 12, 2024
100MG/100ML (1MG/ML)

solution Prescription INTRAVENOUS AP Aug 12, 2024





2. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Midazolam. All of these versions come by the name MIDAZOLAM IN 0.9% SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/50ML (1MG/ML)

solution Prescription INTRAVENOUS AP Apr 17, 2023
100MG/100ML (1MG/ML)

solution Prescription INTRAVENOUS AP Apr 17, 2023


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC