NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as ENTASIS THERAP. It is marketed under 1 brand name, including XACDURO (COPACKAGED). Available in 1 different strength, such as EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL, and administered through 1 route including 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":"115323","ingredient":"DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM","trade_name":"XACDURO (COPACKAGED)","family_id":"2c4ca4e91fa24a5f8c88","publication_number":"US9309245B2","cleaned_patent_number":"9309245","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-02","publication_date":"2016-04-12","legal_status":"Granted"} | US9309245B2 Molecular | 12 Apr, 2016 | Granted | 02 Apr, 2033 | |
| {"application_id":"115361","ingredient":"DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM","trade_name":"XACDURO (COPACKAGED)","family_id":"2c4ca4e91fa24a5f8c88","publication_number":"US9623014B2","cleaned_patent_number":"9623014","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-02","publication_date":"2017-04-18","legal_status":"Granted"} | US9623014B2 | 18 Apr, 2017 | Granted | 02 Apr, 2033 | |
| {"application_id":"115394","ingredient":"DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM","trade_name":"XACDURO (COPACKAGED)","family_id":"171a2f2a454546ceb125","publication_number":"US10376499B2","cleaned_patent_number":"10376499","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-17","publication_date":"2019-08-13","legal_status":"Granted"} | US10376499B2 Formulation | 13 Aug, 2019 | Granted | 17 Nov, 2035 | |
| {"application_id":"115366","ingredient":"DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM","trade_name":"XACDURO (COPACKAGED)","family_id":"171a2f2a454546ceb125","publication_number":"US9968593B2","cleaned_patent_number":"9968593","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-17","publication_date":"2018-05-15","legal_status":"Granted"} | US9968593B2 Formulation | 15 May, 2018 | Granted | 17 Nov, 2035 |
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.