NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as CATALYST PHARMS. It is marketed under 1 brand name, including FIRDAPSE. Available in 1 different strength, such as EQ 10MG BASE, and administered through 1 route including TABLET;ORAL. The latest reported annual revenue is $253,229,083 in 2024.
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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":"93878","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c749a7304c194d52aa07","publication_number":"US11060128B2","cleaned_patent_number":"11060128","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-29","publication_date":"2021-07-13","legal_status":"Granted"} | US11060128B2 | 13 Jul, 2021 | Granted | 29 Jun, 2032 | |
| {"application_id":"93875","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c749a7304c194d52aa07","publication_number":"US11268128B2","cleaned_patent_number":"11268128","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-29","publication_date":"2022-03-08","legal_status":"Granted"} | US11268128B2 | 08 Mar, 2022 | Granted | 29 Jun, 2032 | |
| {"application_id":"93879","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c749a7304c194d52aa07","publication_number":"US11274331B2","cleaned_patent_number":"11274331","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-29","publication_date":"2022-03-15","legal_status":"Granted"} | US11274331B2 | 15 Mar, 2022 | Granted | 29 Jun, 2032 | |
| {"application_id":"93880","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c749a7304c194d52aa07","publication_number":"US11274332B2","cleaned_patent_number":"11274332","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-29","publication_date":"2022-03-15","legal_status":"Granted"} | US11274332B2 | 15 Mar, 2022 | Granted | 29 Jun, 2032 | |
| {"application_id":"93877","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c749a7304c194d52aa07","publication_number":"US10793893B2","cleaned_patent_number":"10793893","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-26","publication_date":"2020-10-06","legal_status":"Granted"} | US10793893B2 | 06 Oct, 2020 | Granted | 26 May, 2034 | |
| {"application_id":"105988","ingredient":"AMIFAMPRIDINE PHOSPHATE","trade_name":"FIRDAPSE","family_id":"c7aa091e3c804e12b4dd","publication_number":"US10626088B2","cleaned_patent_number":"10626088","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-25","publication_date":"2020-04-21","legal_status":"Granted"} | US10626088B2 Formulation | 21 Apr, 2020 | Granted | 25 Feb, 2037 |
Country wise drug prices over the years
Country wise drug revenue over the years
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.