NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 5 pharmaceutical companies such as ALLERGAN, HISAMITSU, ALEMBIC and others. It is marketed under 3 brand names, including SAPHRIS, SECUADO, ASENAPINE MALEATE. Available in 6 different strengths, such as EQ 2.5MG BASE, 5.7MG/24HR, 7.6MG/24HR and others, and administered through 2 routes including TABLET;SUBLINGUAL, SYSTEM;TRANSDERMAL.
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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":"104582","ingredient":"ASENAPINE MALEATE","trade_name":"SAPHRIS","family_id":"97634d1b816f4c66b07b","publication_number":"US8022228B2","cleaned_patent_number":"8022228","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-10-06","publication_date":"2011-09-20","legal_status":"Granted"} | US8022228B2 | 20 Sep, 2011 | Granted | 06 Oct, 2026 | |
| {"application_id":"104581","ingredient":"ASENAPINE MALEATE","trade_name":"SAPHRIS","family_id":"97634d1b816f4c66b07b","publication_number":"US7741358B2","cleaned_patent_number":"7741358","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-10-06","publication_date":"2010-06-22","legal_status":"Granted"} | US7741358B2 | 22 Jun, 2010 | Granted | 06 Oct, 2026 | |
| {"application_id":"83730","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US10814002B2","cleaned_patent_number":"10814002","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2020-10-27","legal_status":"Granted"} | US10814002B2 Formulation | 27 Oct, 2020 | Granted | 25 Jul, 2033 | |
| {"application_id":"83731","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US11123305B2","cleaned_patent_number":"11123305","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2021-09-21","legal_status":"Granted"} | US11123305B2 Formulation | 21 Sep, 2021 | Granted | 25 Jul, 2033 | |
| {"application_id":"83727","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US10022445B2","cleaned_patent_number":"10022445","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2018-07-17","legal_status":"Granted"} | US10022445B2 Formulation | 17 Jul, 2018 | Granted | 25 Jul, 2033 | |
| {"application_id":"83700","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US10583121B2","cleaned_patent_number":"10583121","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2020-03-10","legal_status":"Granted"} | US10583121B2 Formulation | 10 Mar, 2020 | Granted | 25 Jul, 2033 | |
| {"application_id":"83726","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US9687474B2","cleaned_patent_number":"9687474","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-25","publication_date":"2017-06-27","legal_status":"Granted"} | US9687474B2 Formulation | 27 Jun, 2017 | Granted | 25 Jul, 2033 | |
| {"application_id":"121157","ingredient":"ASENAPINE","trade_name":"SECUADO","family_id":"af68aec06c8d4ddaae1f","publication_number":"US11813364B2","cleaned_patent_number":"11813364","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-22","publication_date":"2023-11-14","legal_status":"Patented case"} | US11813364B2 Formulation | 14 Nov, 2023 | Patented case | 22 Sep, 2033 |
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.