NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as NOVARTIS. It is marketed under 1 brand name, including FABHALTA. Available in 1 different strength, such as EQ 200MG 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 |
|---|
Patents approved by the FDA for the ingredient
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|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"119392","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"53a12ae9ff4c403b922f","publication_number":"US10093663B2","cleaned_patent_number":"10093663","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-14","publication_date":"2018-10-09","legal_status":"Granted"} | US10093663B2 | 09 Oct, 2018 | Granted | 14 Jul, 2034 | |
| {"application_id":"119351","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"53a12ae9ff4c403b922f","publication_number":"US9682968B2","cleaned_patent_number":"9682968","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-14","publication_date":"2017-06-20","legal_status":"Granted"} | US9682968B2 Molecular Formulation | 20 Jun, 2017 | Granted | 14 Jul, 2034 | |
| {"application_id":"113338","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"5216687e92bb4646b313","publication_number":"US11723901B2","cleaned_patent_number":"11723901","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-30","publication_date":"2023-08-15","legal_status":"Granted"} | US11723901B2 | 15 Aug, 2023 | Granted | 30 Aug, 2038 | |
| {"application_id":"113339","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"5216687e92bb4646b313","publication_number":"US20220152011A1","cleaned_patent_number":"12285422","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-30","publication_date":"2022-05-19","legal_status":"Pending"} | US12285422B2 | 19 May, 2022 | Pending | 30 Aug, 2038 | |
| {"application_id":"119018","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"30544cd8cd1e47bb8f30","publication_number":"US11603363B2","cleaned_patent_number":"11603363","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-05-25","publication_date":"2023-03-14","legal_status":"Granted"} | US11603363B2 Molecular Formulation | 14 Mar, 2023 | Granted | 25 May, 2041 | |
| {"application_id":"123297","ingredient":"IPTACOPAN HYDROCHLORIDE","trade_name":"FABHALTA","family_id":"","publication_number":"US11951101B2","cleaned_patent_number":"11951101","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-07-15","publication_date":"2024-04-09","legal_status":"Granted"} | US11951101B2 | 09 Apr, 2024 | Granted | 15 Jul, 2041 |
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.