NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 12 pharmaceutical companies such as NORVIUM BIOSCIENCE, ENDO OPERATIONS, CHARTWELL RX and others. It is marketed under 1 brand name, including FENOFIBRIC ACID. Available in 2 different strengths, such as EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID, and administered through 1 route including CAPSULE, DELAYED 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":"44054","ingredient":"CHOLINE FENOFIBRATE","trade_name":"TRILIPIX","family_id":"d50f5e4a71e841bdac37","publication_number":"US7259186B2","cleaned_patent_number":"7259186","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-01-07","publication_date":"2007-08-21","legal_status":"Granted"} | US7259186B2 Molecular | 21 Aug, 2007 | Granted | 07 Jan, 2025 |
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.