NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as EMERGENT BIODEFENSE. It is marketed under 1 brand name, including TEMBEXA. Available in 2 different strengths, such as 10MG/ML, 100MG, and administered through 2 routes including SUSPENSION;ORAL, TABLET;ORAL.
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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":"83206","ingredient":"BRINCIDOFOVIR","trade_name":"TEMBEXA","family_id":"6b7b5246a3814710be14","publication_number":"US9303051B2","cleaned_patent_number":"9303051","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-31","publication_date":"2016-04-05","legal_status":"Granted"} | US9303051B2 Molecular Formulation | 05 Apr, 2016 | Granted | 31 Aug, 2031 | |
| {"application_id":"100988","ingredient":"BRINCIDOFOVIR","trade_name":"TEMBEXA","family_id":"b38e616ff6954513935d","publication_number":"US10112909B2","cleaned_patent_number":"10112909","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2018-10-30","legal_status":"Granted"} | US10112909B2 | 30 Oct, 2018 | Granted | 10 Oct, 2034 | |
| {"application_id":"101013","ingredient":"BRINCIDOFOVIR","trade_name":"TEMBEXA","family_id":"b38e616ff6954513935d","publication_number":"US10487061B2","cleaned_patent_number":"10487061","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2019-11-26","legal_status":"Patented case"} | US10487061B2 Formulation | 26 Nov, 2019 | Patented case | 10 Oct, 2034 | |
| {"application_id":"101010","ingredient":"BRINCIDOFOVIR","trade_name":"TEMBEXA","family_id":"b38e616ff6954513935d","publication_number":"US8962829B1","cleaned_patent_number":"8962829","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2015-02-24","legal_status":"Patented case"} | US8962829B2 Molecular Formulation | 24 Feb, 2015 | Patented case | 10 Oct, 2034 | |
| {"application_id":"101011","ingredient":"BRINCIDOFOVIR","trade_name":"TEMBEXA","family_id":"b38e616ff6954513935d","publication_number":"US9371344B2","cleaned_patent_number":"9371344","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2016-06-21","legal_status":"Granted"} | US9371344B2 Formulation | 21 Jun, 2016 | Granted | 10 Oct, 2034 |
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.