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 EXONDYS 51. Available in 2 different strengths, such as 100MG/2ML (50MG/ML), 500MG/10ML (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":"72928","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ace4e9f25af94c658299","publication_number":"USRE47751E","cleaned_patent_number":"RE47751","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2019-12-03","legal_status":"Granted"} | USRE47751E1 | 03 Dec, 2019 | Granted | 28 Jun, 2025 | |
| {"application_id":"72918","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ace4e9f25af94c658299","publication_number":"US9018368B2","cleaned_patent_number":"9018368","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2015-04-28","legal_status":"Granted"} | US9018368B2 Molecular Formulation | 28 Apr, 2015 | Granted | 28 Jun, 2025 | |
| {"application_id":"72934","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ace4e9f25af94c658299","publication_number":"US10781451B2","cleaned_patent_number":"10781451","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2020-09-22","legal_status":"Expired"} | US10781451B2 Molecular Formulation | 22 Sep, 2020 | Expired | 28 Jun, 2025 | |
| {"application_id":"73659","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"0265a84d87fb41b4b994","publication_number":"USRE48468E","cleaned_patent_number":"RE48468","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-27","publication_date":"2021-03-16","legal_status":"Granted"} | USRE48468E1 | 16 Mar, 2021 | Granted | 27 Oct, 2028 | |
| {"application_id":"72929","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ace4e9f25af94c658299","publication_number":"USRE47769E","cleaned_patent_number":"RE47769","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-02","publication_date":"2019-12-17","legal_status":"Expired"} | USRE47769E1 Formulation | 17 Dec, 2019 | Expired | 02 Feb, 2029 | |
| {"application_id":"73562","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ae241152b9d34739a959","publication_number":"US9506058B2","cleaned_patent_number":"9506058","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2016-11-29","legal_status":"Granted"} | US9506058B2 | 29 Nov, 2016 | Granted | 14 Mar, 2034 | |
| {"application_id":"73585","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ae241152b9d34739a959","publication_number":"US10364431B2","cleaned_patent_number":"10364431","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2019-07-30","legal_status":"Granted"} | US10364431B2 | 30 Jul, 2019 | Granted | 14 Mar, 2034 | |
| {"application_id":"73584","ingredient":"ETEPLIRSEN","trade_name":"EXONDYS 51","family_id":"ae241152b9d34739a959","publication_number":"US10337003B2","cleaned_patent_number":"10337003","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2019-07-02","legal_status":"Granted"} | US10337003B2 | 02 Jul, 2019 | Granted | 14 Mar, 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.