NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 6 pharmaceutical companies such as SENORES PHARMS, CYPRESS PHARM, MISSION PHARMACAL and others. It is marketed under 2 brand names, including CARBINOXAMINE MALEATE, KARBINAL ER. Available in 3 different strengths, such as 4MG, 4MG/5ML, 6MG, and administered through 3 routes including TABLET;ORAL, SOLUTION;ORAL, SUSPENSION, EXTENDED RELEASE;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 | |
|---|---|---|---|---|---|
| {"application_id":"57918","ingredient":"CARBINOXAMINE MALEATE","trade_name":"KARBINAL ER","family_id":"ab746e06a067453e8066","publication_number":"US9522191B2","cleaned_patent_number":"9522191","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-15","publication_date":"2016-12-20","legal_status":"Granted"} | US9522191B2 Formulation | 20 Dec, 2016 | Granted | 15 Jun, 2027 | |
| {"application_id":"57892","ingredient":"CARBINOXAMINE MALEATE","trade_name":"KARBINAL ER","family_id":"ab746e06a067453e8066","publication_number":"US8062667B2","cleaned_patent_number":"8062667","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-29","publication_date":"2011-11-22","legal_status":"Granted"} | US8062667B2 Formulation | 22 Nov, 2011 | Granted | 29 Mar, 2029 |
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.