NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as BIOCRYST. It is marketed under 1 brand name, including ORLADEYO. Available in 2 different strengths, such as EQ 110MG BASE, EQ 150MG BASE, and administered through 1 route including CAPSULE;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":"50045","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"6deec5d9595a44efbf83","publication_number":"US11230530B2","cleaned_patent_number":"11230530","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-09","publication_date":"2022-01-25","legal_status":"Granted"} | US11230530B2 | 25 Jan, 2022 | Granted | 09 Mar, 2035 | |
| {"application_id":"50084","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"6deec5d9595a44efbf83","publication_number":"US10329260B2","cleaned_patent_number":"10329260","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-09","publication_date":"2019-06-25","legal_status":"Granted"} | US10329260B2 Molecular | 25 Jun, 2019 | Granted | 09 Mar, 2035 | |
| {"application_id":"138442","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"","publication_number":"US12116346B2","cleaned_patent_number":"12116346","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-09","publication_date":"2024-10-15","legal_status":"Granted"} | US12116346B2 Molecular | 15 Oct, 2024 | Granted | 09 Mar, 2035 | |
| {"application_id":"50086","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"6deec5d9595a44efbf83","publication_number":"US10689346B2","cleaned_patent_number":"10689346","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-09","publication_date":"2020-06-23","legal_status":"Granted"} | US10689346B2 | 23 Jun, 2020 | Granted | 09 Mar, 2035 | |
| {"application_id":"114870","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"203939d2844e46eeb5d7","publication_number":"US11708333B2","cleaned_patent_number":"11708333","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-09","publication_date":"2023-07-25","legal_status":"Granted"} | US11708333B2 | 25 Jul, 2023 | Granted | 09 Mar, 2035 | |
| {"application_id":"50083","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"6deec5d9595a44efbf83","publication_number":"US10125102B2","cleaned_patent_number":"10125102","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-07","publication_date":"2018-11-13","legal_status":"Granted"} | US10125102B2 Molecular | 13 Nov, 2018 | Granted | 07 Apr, 2035 | |
| {"application_id":"39105","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"46dc48cba49b466794ca","publication_number":"US11618733B2","cleaned_patent_number":"11618733","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-11-01","publication_date":"2023-04-04","legal_status":"Granted"} | US11618733B2 | 04 Apr, 2023 | Granted | 01 Nov, 2039 | |
| {"application_id":"27475","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"46dc48cba49b466794ca","publication_number":"US11117867B2","cleaned_patent_number":"11117867","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-11-01","publication_date":"2021-09-14","legal_status":"Granted"} | US11117867B2 Formulation | 14 Sep, 2021 | Granted | 01 Nov, 2039 | |
| {"application_id":"27474","ingredient":"BEROTRALSTAT HYDROCHLORIDE","trade_name":"ORLADEYO","family_id":"46dc48cba49b466794ca","publication_number":"US10662160B1","cleaned_patent_number":"10662160","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-11-01","publication_date":"2020-05-26","legal_status":"Granted"} | US10662160B2 Molecular | 26 May, 2020 | Granted | 01 Nov, 2039 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.