NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as AKCEA THERAPS. It is marketed under 1 brand name, including TEGSEDI. Available in 1 different strength, such as EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML), and administered through 1 route including SOLUTION;SUBCUTANEOUS.
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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":"80128","ingredient":"INOTERSEN SODIUM","trade_name":"TEGSEDI","family_id":"fecc0b10fa9f4e368cb0","publication_number":"US8101743B2","cleaned_patent_number":"8101743","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-04-01","publication_date":"2012-01-24","legal_status":"Granted"} | US8101743B2 Molecular Formulation | 24 Jan, 2012 | Granted | 01 Apr, 2025 | |
| {"application_id":"80118","ingredient":"INOTERSEN SODIUM","trade_name":"TEGSEDI","family_id":"55665a46bd094b1293a9","publication_number":"US8697860B1","cleaned_patent_number":"8697860","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-29","publication_date":"2014-04-15","legal_status":"Granted"} | US8697860B2 Formulation | 15 Apr, 2014 | Granted | 29 Apr, 2031 | |
| {"application_id":"80119","ingredient":"INOTERSEN SODIUM","trade_name":"TEGSEDI","family_id":"55665a46bd094b1293a9","publication_number":"US9061044B2","cleaned_patent_number":"9061044","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-29","publication_date":"2015-06-23","legal_status":"Granted"} | US9061044B2 Molecular | 23 Jun, 2015 | Granted | 29 Apr, 2031 | |
| {"application_id":"80090","ingredient":"INOTERSEN SODIUM","trade_name":"TEGSEDI","family_id":"55665a46bd094b1293a9","publication_number":"US9399774B2","cleaned_patent_number":"9399774","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-29","publication_date":"2016-07-26","legal_status":"Granted"} | US9399774B2 | 26 Jul, 2016 | Granted | 29 Apr, 2031 |
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.