NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 62 pharmaceutical companies such as TARO, PHARMOBEDIENT CNSLTG, FRESENIUS KABI USA and others. It is marketed under 4 brand names, including LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, SPRITAM and others. Available in 11 different strengths, such as 250MG, 1GM, 500MG and others, and administered through 5 routes including TABLET;ORAL, SOLUTION;ORAL, INJECTABLE;INTRAVENOUS and others.
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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":"85044","ingredient":"LEVETIRACETAM","trade_name":"ELEPSIA XR","family_id":"ddfc66d849034715a334","publication_number":"US8425938B2","cleaned_patent_number":"8425938","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-02-22","publication_date":"2013-04-23","legal_status":"Granted"} | US8425938B2 Formulation | 23 Apr, 2013 | Granted | 22 Feb, 2026 | |
| {"application_id":"85045","ingredient":"LEVETIRACETAM","trade_name":"ELEPSIA XR","family_id":"ddfc66d849034715a334","publication_number":"US8535717B2","cleaned_patent_number":"8535717","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-02-22","publication_date":"2013-09-17","legal_status":"Granted"} | US8535717B2 Formulation | 17 Sep, 2013 | Granted | 22 Feb, 2026 | |
| {"application_id":"85049","ingredient":"LEVETIRACETAM","trade_name":"ELEPSIA XR","family_id":"49b7a5c8bbb94c20b00a","publication_number":"US8163306B2","cleaned_patent_number":"8163306","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-03","publication_date":"2012-04-24","legal_status":"Granted"} | US8163306B2 Formulation | 24 Apr, 2012 | Granted | 03 Sep, 2027 | |
| {"application_id":"85041","ingredient":"LEVETIRACETAM","trade_name":"ELEPSIA XR","family_id":"ddfc66d849034715a334","publication_number":"US8431156B2","cleaned_patent_number":"8431156","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-31","publication_date":"2013-04-30","legal_status":"Granted"} | US8431156B2 Formulation | 30 Apr, 2013 | Granted | 31 Oct, 2027 | |
| {"application_id":"85069","ingredient":"LEVETIRACETAM","trade_name":"ELEPSIA XR","family_id":"49b7a5c8bbb94c20b00a","publication_number":"US8470367B2","cleaned_patent_number":"8470367","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-31","publication_date":"2013-06-25","legal_status":"Granted"} | US8470367B2 Formulation | 25 Jun, 2013 | Granted | 31 Oct, 2027 | |
| {"application_id":"86260","ingredient":"LEVETIRACETAM","trade_name":"KEPPRA XR","family_id":"62b92131430643a58c50","publication_number":"US7858122B2","cleaned_patent_number":"7858122","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-17","publication_date":"2010-12-28","legal_status":"Granted"} | US7858122B2 Formulation | 28 Dec, 2010 | Granted | 17 Sep, 2028 | |
| {"application_id":"95188","ingredient":"LEVETIRACETAM","trade_name":"KEPPRA","family_id":"ede83dc1126744bf9913","publication_number":"US8802142B2","cleaned_patent_number":"8802142","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-12-07","publication_date":"2014-08-12","legal_status":"Granted"} | US8802142B2 | 12 Aug, 2014 | Granted | 07 Dec, 2031 | |
| {"application_id":"88581","ingredient":"LEVETIRACETAM","trade_name":"SPRITAM","family_id":"d7d63aef74994c2c92f6","publication_number":"US9669009B2","cleaned_patent_number":"9669009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2017-06-06","legal_status":"Granted"} | US9669009B2 | 06 Jun, 2017 | Granted | 14 Mar, 2034 | |
| {"application_id":"88565","ingredient":"LEVETIRACETAM","trade_name":"SPRITAM","family_id":"d7d63aef74994c2c92f6","publication_number":"US9339489B2","cleaned_patent_number":"9339489","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2016-05-17","legal_status":"Granted"} | US9339489B2 Formulation | 17 May, 2016 | Granted | 14 Mar, 2034 | |
| {"application_id":"88582","ingredient":"LEVETIRACETAM","trade_name":"SPRITAM","family_id":"d7d63aef74994c2c92f6","publication_number":"US11160786B2","cleaned_patent_number":"11160786","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2021-11-02","legal_status":"Patented case"} | US11160786B2 Formulation | 02 Nov, 2021 | Patented case | 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.