NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as ABBVIE, APOTEX. It is marketed under 2 brand names, including TEFLARO, CEFTAROLINE FOSAMIL. Available in 2 different strengths, such as 400MG/VIAL, 600MG/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":"36874","ingredient":"CEFTAROLINE FOSAMIL","trade_name":"TEFLARO","family_id":"0296148d9e5448cd9f4f","publication_number":"US9629861B2","cleaned_patent_number":"9629861","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-21","publication_date":"2017-04-25","legal_status":"Granted"} | US9629861B2 Formulation | 25 Apr, 2017 | Granted | 21 Sep, 2030 | |
| {"application_id":"36909","ingredient":"CEFTAROLINE FOSAMIL","trade_name":"TEFLARO","family_id":"eaa1caf185804e1eb469","publication_number":"US8247400B2","cleaned_patent_number":"8247400","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-10","publication_date":"2012-08-21","legal_status":"Granted"} | US8247400B2 Formulation | 21 Aug, 2012 | Granted | 10 Feb, 2031 |
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.