NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 27 pharmaceutical companies such as TEVA PHARMS USA, AUSTARPHARMA, AJANTA PHARMA LTD and others. It is marketed under 2 brand names, including SOLIFENACIN SUCCINATE, VESICARE LS. Available in 3 different strengths, such as 5MG, 10MG, 1MG/ML, and administered through 2 routes including TABLET;ORAL, SUSPENSION;ORAL.
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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 | |
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| {"application_id":"83261","ingredient":"SOLIFENACIN SUCCINATE","trade_name":"VESICARE LS","family_id":"3d8a5a09247f47b89a06","publication_number":"US9918970B2","cleaned_patent_number":"9918970","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-18","publication_date":"2018-03-20","legal_status":"Granted"} | US9918970B2 Formulation | 20 Mar, 2018 | Granted | 18 May, 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.