NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 11 pharmaceutical companies such as ACROTECH BIOPHARMA, SANDOZ, NORVIUM BIOSCIENCE and others. It is marketed under 3 brand names, including FUSILEV, LEVOLEUCOVORIN CALCIUM, KHAPZORY. Available in 6 different strengths, such as EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML), EQ 250MG BASE/25ML (EQ 10MG BASE/ML), EQ 50MG BASE/VIAL and others, and administered through 2 routes including SOLUTION;INTRAVENOUS, POWDER;INTRAVENOUS.
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FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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":"110535","ingredient":"LEVOLEUCOVORIN","trade_name":"KHAPZORY","family_id":"afdeb95621844dfbbacb","publication_number":"US11541012B1","cleaned_patent_number":"11541012","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-25","publication_date":"2023-01-03","legal_status":"Granted"} | US11541012B2 Formulation | 03 Jan, 2023 | Granted | 25 Mar, 2039 |
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
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.