NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as GILEAD, FRESENIUS KABI USA, HIKMA and others. It is marketed under 3 brand names, including CAYSTON, AZTREONAM, EMBLAVEO. Available in 5 different strengths, such as 75MG/VIAL, 1GM/VIAL, 2GM/VIAL and others, and administered through 3 routes including FOR SOLUTION;INHALATION, INJECTABLE;INJECTION, POWDER;INTRAVENOUS.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"38194","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"c96be9423e70496aa9a4","publication_number":"US7112592B2","cleaned_patent_number":"7112592","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-07","publication_date":"2006-09-26","legal_status":"Expired"} | US7112592B2 Molecular Formulation | 26 Sep, 2006 | Expired | 07 Jan, 2026 | |
| {"application_id":"1786","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"25b4c162999d426eab63","publication_number":"US7612087B2","cleaned_patent_number":"7612087","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-12","publication_date":"2009-11-03","legal_status":"Granted"} | US7612087B2 Formulation | 03 Nov, 2009 | Granted | 12 Nov, 2026 | |
| {"application_id":"37090","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"5ae9b9e8331c429887fd","publication_number":"US8835455B2","cleaned_patent_number":"8835455","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-08","publication_date":"2014-09-16","legal_status":"Granted"} | US8835455B2 Formulation | 16 Sep, 2014 | Granted | 08 Oct, 2030 | |
| {"application_id":"37089","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"5ae9b9e8331c429887fd","publication_number":"US8471025B2","cleaned_patent_number":"8471025","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-12","publication_date":"2013-06-25","legal_status":"Granted"} | US8471025B2 Molecular | 25 Jun, 2013 | Granted | 12 Aug, 2031 | |
| {"application_id":"36559","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"57cf556e6955403eb268","publication_number":"US8969566B2","cleaned_patent_number":"8969566","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-15","publication_date":"2015-03-03","legal_status":"Granted"} | US8969566B2 Molecular | 03 Mar, 2015 | Granted | 15 Jun, 2032 | |
| {"application_id":"36561","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"57cf556e6955403eb268","publication_number":"US9284314B2","cleaned_patent_number":"9284314","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-15","publication_date":"2016-03-15","legal_status":"Granted"} | US9284314B2 Molecular | 15 Mar, 2016 | Granted | 15 Jun, 2032 | |
| {"application_id":"36560","ingredient":"AVIBACTAM SODIUM; AZTREONAM","trade_name":"EMBLAVEO","family_id":"57cf556e6955403eb268","publication_number":"US9695122B2","cleaned_patent_number":"9695122","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-15","publication_date":"2017-07-04","legal_status":"Granted"} | US9695122B2 Molecular Formulation | 04 Jul, 2017 | Granted | 15 Jun, 2032 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.