NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 11 pharmaceutical companies such as BAXTER HLTHCARE, HOSPIRA, AUROBINDO PHARMA LTD and others. It is marketed under 3 brand names, including NEXTERONE, AMIODARONE HYDROCHLORIDE, PACERONE. Available in 6 different strengths, such as 150MG/100ML (1.5MG/ML), 360MG/200ML (1.8MG/ML), 50MG/ML and others, and administered through 2 routes including INJECTABLE;INJECTION, TABLET;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 | |
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| {"application_id":"40775","ingredient":"AMIODARONE HYDROCHLORIDE","trade_name":"NEXTERONE","family_id":"3ecf95748df94158a713","publication_number":"US7635773B2","cleaned_patent_number":"7635773","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-13","publication_date":"2009-12-22","legal_status":"Granted"} | US7635773B2 Formulation | 22 Dec, 2009 | Granted | 13 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.