NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 23 pharmaceutical companies such as APPCO, PIRAMAL CRITICAL, AMNEAL and others. It is marketed under 6 brand names, including BACLOFEN, GABLOFEN, OZOBAX and others. Available in 14 different strengths, such as 10MG, 20MG, 0.05MG/ML and others, and administered through 5 routes including TABLET;ORAL, INJECTABLE;INTRATHECAL, SOLUTION;ORAL and others.
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Licensing: 23 potential partnersUS Launch window: Loading launch window...
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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":"108145","ingredient":"BACLOFEN","trade_name":"FLEQSUVY","family_id":"731aa55310b649eb931a","publication_number":"US11446246B2","cleaned_patent_number":"11446246","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-09-08","publication_date":"2022-09-20","legal_status":"Granted"} | US11446246B2 | 20 Sep, 2022 | Granted | 08 Sep, 2037 | |
| {"application_id":"82895","ingredient":"BACLOFEN","trade_name":"FLEQSUVY","family_id":"731aa55310b649eb931a","publication_number":"US11324696B2","cleaned_patent_number":"11324696","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-09-29","publication_date":"2022-05-10","legal_status":"Granted"} | US11324696B2 Formulation | 10 May, 2022 | Granted | 29 Sep, 2037 | |
| {"application_id":"115158","ingredient":"BACLOFEN","trade_name":"LYVISPAH","family_id":"","publication_number":"US11654124B2","cleaned_patent_number":"11654124","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-29","publication_date":"2023-05-23","legal_status":"Granted"} | US11654124B2 Formulation | 23 May, 2023 | Granted | 29 Jul, 2039 | |
| {"application_id":"60459","ingredient":"BACLOFEN","trade_name":"LYVISPAH","family_id":"e084582779cf46678934","publication_number":"US10792262B1","cleaned_patent_number":"10792262","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-29","publication_date":"2020-10-06","legal_status":"Granted"} | US10792262B2 Formulation | 06 Oct, 2020 | Granted | 29 Jul, 2039 | |
| {"application_id":"122893","ingredient":"BACLOFEN","trade_name":"LYVISPAH","family_id":"","publication_number":"US11931328B2","cleaned_patent_number":"11931328","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-29","publication_date":"2024-03-19","legal_status":"Granted"} | US11931328B2 Formulation | 19 Mar, 2024 | Granted | 29 Jul, 2039 | |
| {"application_id":"76696","ingredient":"BACLOFEN","trade_name":"OZOBAX","family_id":"12c36b5c403d47ffa039","publication_number":"US10610502B1","cleaned_patent_number":"10610502","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2020-04-07","legal_status":"Granted"} | US10610502B2 | 07 Apr, 2020 | Granted | 30 Aug, 2039 | |
| {"application_id":"120693","ingredient":"BACLOFEN","trade_name":"LYVISPAH","family_id":"33074fd1aaa2430bbe48","publication_number":"US11850225B2","cleaned_patent_number":"11850225","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-09-29","publication_date":"2023-12-26","legal_status":"Granted"} | US11850225B2 Formulation | 26 Dec, 2023 | Granted | 29 Sep, 2041 | |
| {"application_id":"109894","ingredient":"BACLOFEN","trade_name":"LYVISPAH","family_id":"33074fd1aaa2430bbe48","publication_number":"US11491125B1","cleaned_patent_number":"11491125","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-09-29","publication_date":"2022-11-08","legal_status":"Patented case"} | US11491125B2 Formulation | 08 Nov, 2022 | Patented case | 29 Sep, 2041 |
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.