NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as BIOGEN IDEC. It is marketed under 1 brand name, including SPINRAZA. Available in 1 different strength, such as EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML), and administered through 1 route including SOLUTION;INTRATHECAL.
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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":"71886","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"adb4f6df79d744098c24","publication_number":"US10266822B2","cleaned_patent_number":"10266822","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-05","publication_date":"2019-04-23","legal_status":"Granted"} | US10266822B2 | 23 Apr, 2019 | Granted | 05 Dec, 2025 | |
| {"application_id":"71882","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"adb4f6df79d744098c24","publication_number":"US8110560B2","cleaned_patent_number":"8110560","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-05","publication_date":"2012-02-07","legal_status":"Granted"} | US8110560B2 | 07 Feb, 2012 | Granted | 05 Dec, 2025 | |
| {"application_id":"71883","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"adb4f6df79d744098c24","publication_number":"US7838657B2","cleaned_patent_number":"7838657","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-11","publication_date":"2010-11-23","legal_status":"Granted"} | US7838657B2 Molecular | 23 Nov, 2010 | Granted | 11 Jul, 2027 | |
| {"application_id":"71890","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"8515429cb6a0481da84c","publication_number":"US9717750B2","cleaned_patent_number":"9717750","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-17","publication_date":"2017-08-01","legal_status":"Granted"} | US9717750B2 | 01 Aug, 2017 | Granted | 17 Jun, 2030 | |
| {"application_id":"71941","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"8515429cb6a0481da84c","publication_number":"US8980853B2","cleaned_patent_number":"8980853","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-24","publication_date":"2015-03-17","legal_status":"Granted"} | US8980853B2 | 17 Mar, 2015 | Granted | 24 Nov, 2030 | |
| {"application_id":"71972","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"a162f70829b04a49b8f6","publication_number":"US8361977B2","cleaned_patent_number":"8361977","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-23","publication_date":"2013-01-29","legal_status":"Granted"} | US8361977B2 Molecular Formulation | 29 Jan, 2013 | Granted | 23 Dec, 2030 | |
| {"application_id":"71961","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"162277180fa640ca9bfa","publication_number":"US9926559B2","cleaned_patent_number":"9926559","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-01-09","publication_date":"2018-03-27","legal_status":"Granted"} | US9926559B2 | 27 Mar, 2018 | Granted | 09 Jan, 2034 | |
| {"application_id":"71948","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"a83617091eec4b12a649","publication_number":"US10436802B2","cleaned_patent_number":"10436802","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-11","publication_date":"2019-10-08","legal_status":"Granted"} | US10436802B2 | 08 Oct, 2019 | Granted | 11 Sep, 2035 | |
| {"application_id":"71953","ingredient":"NUSINERSEN SODIUM","trade_name":"SPINRAZA","family_id":"a83617091eec4b12a649","publication_number":"US12013403B2","cleaned_patent_number":"12013403","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-03-04","publication_date":"2024-06-18","legal_status":"Granted"} | US12013403B2 | 18 Jun, 2024 | Granted | 04 Mar, 2036 |
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.