NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as AM REGENT, NORVIUM BIOSCIENCE, LUPIN and others. It is marketed under 2 brand names, including FOSPHENYTOIN SODIUM, SESQUIENT. Available in 3 different strengths, such as EQ 50MG PHENYTOIN NA/ML, EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML), EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML), and administered through 2 routes including INJECTABLE;INJECTION, SOLUTION;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":"40775","ingredient":"FOSPHENYTOIN SODIUM","trade_name":"SESQUIENT","family_id":"3ecf95748df94158a713","publication_number":"US7635773B2","cleaned_patent_number":"7635773","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-13","publication_date":"2009-12-22","legal_status":"Granted"} | US7635773B2 Formulation | 22 Dec, 2009 | Granted | 13 Mar, 2029 | |
| {"application_id":"2455","ingredient":"FOSPHENYTOIN SODIUM","trade_name":"SESQUIENT","family_id":"3ecf95748df94158a713","publication_number":"US8410077B2","cleaned_patent_number":"8410077","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-13","publication_date":"2013-04-02","legal_status":"Granted"} | US8410077B2 Formulation | 02 Apr, 2013 | Granted | 13 Mar, 2029 | |
| {"application_id":"40776","ingredient":"FOSPHENYTOIN SODIUM","trade_name":"SESQUIENT","family_id":"3ecf95748df94158a713","publication_number":"US9200088B2","cleaned_patent_number":"9200088","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-13","publication_date":"2015-12-01","legal_status":"Granted"} | US9200088B2 Formulation | 01 Dec, 2015 | Granted | 13 Mar, 2029 | |
| {"application_id":"40752","ingredient":"FOSPHENYTOIN SODIUM","trade_name":"SESQUIENT","family_id":"3ecf95748df94158a713","publication_number":"US9750822B2","cleaned_patent_number":"9750822","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-13","publication_date":"2017-09-05","legal_status":"Granted"} | US9750822B2 Formulation | 05 Sep, 2017 | Granted | 13 Mar, 2029 | |
| {"application_id":"34843","ingredient":"FOSPHENYTOIN SODIUM","trade_name":"SESQUIENT","family_id":"63f22001fd064021a5c0","publication_number":"US9493582B2","cleaned_patent_number":"9493582","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2016-11-15","legal_status":"Granted"} | US9493582B2 Formulation | 15 Nov, 2016 | Granted | 27 Feb, 2033 |
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.