NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SAREPTA THERAPS INC. It is marketed under 1 brand name, including AMONDYS 45. Available in 1 different strength, such as 100MG/2ML (50MG/ML), and administered through 1 route including 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":"72879","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"ace4e9f25af94c658299","publication_number":"US9447415B2","cleaned_patent_number":"9447415","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2016-09-20","legal_status":"Granted"} | US9447415B2 Molecular Formulation | 20 Sep, 2016 | Granted | 28 Jun, 2025 | |
| {"application_id":"72930","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"ace4e9f25af94c658299","publication_number":"USRE48960E","cleaned_patent_number":"RE48960","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-16","publication_date":"2022-03-08","legal_status":"Granted"} | USRE48960E1 Molecular Formulation | 08 Mar, 2022 | Granted | 16 Feb, 2029 | |
| {"application_id":"72871","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"bb59967fb03f48d49313","publication_number":"US10287586B2","cleaned_patent_number":"10287586","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2019-05-14","legal_status":"Granted"} | US10287586B2 Molecular Formulation | 14 May, 2019 | Granted | 12 Nov, 2030 | |
| {"application_id":"72872","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"bb59967fb03f48d49313","publication_number":"US10781450B2","cleaned_patent_number":"10781450","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2020-09-22","legal_status":"Granted"} | US10781450B2 | 22 Sep, 2020 | Granted | 12 Nov, 2030 | |
| {"application_id":"72870","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"bb59967fb03f48d49313","publication_number":"US9228187B2","cleaned_patent_number":"9228187","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2016-01-05","legal_status":"Granted"} | US9228187B2 Molecular Formulation | 05 Jan, 2016 | Granted | 12 Nov, 2030 | |
| {"application_id":"72831","ingredient":"CASIMERSEN","trade_name":"AMONDYS 45","family_id":"bb59967fb03f48d49313","publication_number":"US9758783B2","cleaned_patent_number":"9758783","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-12","publication_date":"2017-09-12","legal_status":"Granted"} | US9758783B2 | 12 Sep, 2017 | Granted | 12 Nov, 2030 |
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.