Midazolam Patent Expiration
Midazolam was first introduced by Ucb Inc
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
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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 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.
1. B BRAUN MEDICAL
B Braun Medical Inc has filed for 2 different strengths of generic version for Midazolam. All of these versions come by the name MIDAZOLAM IN 0.8% SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by B Braun Medical.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG/50ML (1MG/ML) | solution | Prescription | INTRAVENOUS | N/A | May 1, 2025 |
| 100MG/100ML (1MG/ML) | solution | Prescription | INTRAVENOUS | N/A | May 1, 2025 |
2. GLAND
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.
| 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 |
Manufacturing Plant Locations New
Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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3. 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 |
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| Portugal |
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| Jordan |
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