NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 26 pharmaceutical companies such as NOVARTIS, ACTAVIS INC, MYLAN LABS LTD and others. It is marketed under 3 brand names, including ZOMETA, ZOLEDRONIC ACID, ZOLEDRONIC. Available in 5 different strengths, such as EQ 4MG BASE/100ML, EQ 4MG BASE/5ML, EQ 4MG BASE/VIAL and others, and administered through 2 routes including INJECTABLE;INTRAVENOUS, SOLUTION;INTRAVENOUS.
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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":"62816","ingredient":"ZOLEDRONIC ACID","trade_name":"ZOMETA","family_id":"c235a6159b3448788de2","publication_number":"US8324189B2","cleaned_patent_number":"8324189","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-29","publication_date":"2012-12-04","legal_status":"Granted"} | US8324189B2 | 04 Dec, 2012 | Granted | 29 Nov, 2025 | |
| {"application_id":"62705","ingredient":"ZOLEDRONIC ACID","trade_name":"RECLAST","family_id":"242fad5706c449b78592","publication_number":"US7932241B2","cleaned_patent_number":"7932241","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-05","publication_date":"2011-04-26","legal_status":"Expired"} | US7932241B2 | 26 Apr, 2011 | Expired | 05 Aug, 2028 |
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.