NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 14 pharmaceutical companies such as FRESENIUS KABI USA, NAVINTA LLC, RISING and others. It is marketed under 2 brand names, including NAROPIN, ROPIVACAINE HYDROCHLORIDE. Available in 11 different strengths, such as 500MG/100ML (5MG/ML), 1GM/200ML (5MG/ML), 150MG/30ML (5MG/ML) and others, and administered through 1 route including SOLUTION;INJECTION.
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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":"71414","ingredient":"ROPIVACAINE HYDROCHLORIDE","trade_name":"NAROPIN","family_id":"cb202016405a43bf9ff1","publication_number":"US7828787B2","cleaned_patent_number":"7828787","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-18","publication_date":"2010-11-09","legal_status":"Granted"} | US7828787B2 Formulation | 09 Nov, 2010 | Granted | 18 Oct, 2025 | |
| {"application_id":"71439","ingredient":"ROPIVACAINE HYDROCHLORIDE","trade_name":"NAROPIN","family_id":"588e070334d341e0ac9f","publication_number":"US7857802B2","cleaned_patent_number":"7857802","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-28","publication_date":"2010-12-28","legal_status":"Granted"} | US7857802B2 Formulation | 28 Dec, 2010 | Granted | 28 Nov, 2026 |
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.