NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 3 pharmaceutical companies such as PURDUE PHARMA LP, INDIVIOR, CHENGDU SHUODE. It is marketed under 3 brand names, including NALMEFENE HYDROCHLORIDE, OPVEE, ZURNAI (AUTOINJECTOR). Available in 4 different strengths, such as EQ 2MG BASE/2ML (EQ 1MG BASE/ML), EQ 2.7MG BASE/SPRAY, EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) and others, and administered through 3 routes including SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, SPRAY;NASAL, SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS.
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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":"116207","ingredient":"NALMEFENE HYDROCHLORIDE","trade_name":"OPVEE","family_id":"f853f29b7981441594eb","publication_number":"US11458091B2","cleaned_patent_number":"11458091","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-10","publication_date":"2022-10-04","legal_status":"Granted"} | US11458091B2 Formulation | 04 Oct, 2022 | Granted | 10 Jul, 2038 | |
| {"application_id":"130704","ingredient":"NALMEFENE HYDROCHLORIDE","trade_name":"ZURNAI (AUTOINJECTOR)","family_id":"","publication_number":"US11857547B2","cleaned_patent_number":"11857547","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-11-05","publication_date":"2024-01-02","legal_status":"Granted"} | US11857547B2 Formulation | 02 Jan, 2024 | Granted | 05 Nov, 2039 | |
| {"application_id":"130703","ingredient":"NALMEFENE HYDROCHLORIDE","trade_name":"ZURNAI (AUTOINJECTOR)","family_id":"","publication_number":"US11865112B2","cleaned_patent_number":"11865112","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-11-05","publication_date":"2024-01-09","legal_status":"Granted"} | US11865112B2 Formulation | 09 Jan, 2024 | Granted | 05 Nov, 2039 | |
| {"application_id":"242147","ingredient":"NALMEFENE HYDROCHLORIDE","trade_name":"OPVEE","family_id":"","publication_number":"US12290596B2","cleaned_patent_number":"12290596","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-08-04","publication_date":"2025-05-06","legal_status":"Granted"} | US12290596B2 | 06 May, 2025 | Granted | 04 Aug, 2042 |
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.