NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 12 pharmaceutical companies such as ONESOURCE SPECIALTY, GLAND PHARMA LTD, FRESENIUS KABI USA and others. It is marketed under 8 brand names, including MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE and others. Available in 7 different strengths, such as EQ 5MG BASE/ML, EQ 1MG BASE/ML, EQ 50MG BASE/10ML (EQ 5MG BASE/ML) and others, and administered through 4 routes including INJECTABLE;INJECTION, SOLUTION;INTRAMUSCULAR, SPRAY;NASAL and others.
API availability: Loading API feasibility...
Licensing: 12 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"36878","ingredient":"MIDAZOLAM","trade_name":"NAYZILAM","family_id":"835f50caa99647669a27","publication_number":"US8217033B2","cleaned_patent_number":"8217033","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-18","publication_date":"2012-07-10","legal_status":"Granted"} | US8217033B2 Formulation | 10 Jul, 2012 | Granted | 18 Jan, 2028 | |
| {"application_id":"36877","ingredient":"MIDAZOLAM","trade_name":"NAYZILAM","family_id":"835f50caa99647669a27","publication_number":"US8809322B2","cleaned_patent_number":"8809322","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-18","publication_date":"2014-08-19","legal_status":"Granted"} | US8809322B2 Formulation | 19 Aug, 2014 | Granted | 18 Jan, 2028 | |
| {"application_id":"36879","ingredient":"MIDAZOLAM","trade_name":"NAYZILAM","family_id":"835f50caa99647669a27","publication_number":"US9289432B2","cleaned_patent_number":"9289432","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-18","publication_date":"2016-03-22","legal_status":"Granted"} | US9289432B2 Formulation | 22 Mar, 2016 | Granted | 18 Jan, 2028 | |
| {"application_id":"36880","ingredient":"MIDAZOLAM","trade_name":"NAYZILAM","family_id":"835f50caa99647669a27","publication_number":"US9687495B2","cleaned_patent_number":"9687495","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-18","publication_date":"2017-06-27","legal_status":"Granted"} | US9687495B2 Formulation | 27 Jun, 2017 | Granted | 18 Jan, 2028 | |
| {"application_id":"41015","ingredient":"MIDAZOLAM","trade_name":"MIDAZOLAM IN 0.9% SODIUM CHLORIDE","family_id":"84e0b773b8144fdfb769","publication_number":"US10966990B2","cleaned_patent_number":"10966990","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-20","publication_date":"2021-04-06","legal_status":"Granted"} | US10966990B2 Formulation | 06 Apr, 2021 | Granted | 20 Jun, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Midazolam
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.