NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 0 pharmaceutical companies such as . It is marketed under 0 brand names, including . Available in 0 different strengths, such as , and administered through 0 routes including .
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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":"44232","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US8685444B2","cleaned_patent_number":"8685444","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-03","publication_date":"2014-04-01","legal_status":"Expired"} | US8685444B2 Formulation | 01 Apr, 2014 | Expired | 03 Jul, 2025 | |
| {"application_id":"44215","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US8685443B2","cleaned_patent_number":"8685443","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-03","publication_date":"2014-04-01","legal_status":"Expired"} | US8685443B2 | 01 Apr, 2014 | Expired | 03 Jul, 2025 | |
| {"application_id":"44287","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8158156B2","cleaned_patent_number":"8158156","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2012-04-17","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} | US8158156B2 | 17 Apr, 2012 | Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 | 19 Jun, 2027 | |
| {"application_id":"44236","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US7682633B2","cleaned_patent_number":"7682633","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2010-03-23","legal_status":"Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362"} | US7682633B2 | 23 Mar, 2010 | Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362 | 19 Jun, 2027 | |
| {"application_id":"44286","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US7682634B2","cleaned_patent_number":"7682634","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2010-03-23","legal_status":"Expired"} | US7682634B2 Formulation | 23 Mar, 2010 | Expired | 19 Jun, 2027 | |
| {"application_id":"44288","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8846104B2","cleaned_patent_number":"8846104","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2014-09-30","legal_status":"Expired"} | US8846104B2 Formulation | 30 Sep, 2014 | Expired | 19 Jun, 2027 | |
| {"application_id":"44289","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8877247B2","cleaned_patent_number":"8877247","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2014-11-04","legal_status":"Expired"} | US8877247B2 Formulation | 04 Nov, 2014 | Expired | 19 Jun, 2027 | |
| {"application_id":"44231","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US7815934B2","cleaned_patent_number":"7815934","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-12","publication_date":"2010-10-19","legal_status":"Expired"} | US7815934B2 Formulation | 19 Oct, 2010 | Expired | 12 Dec, 2027 | |
| {"application_id":"44297","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"bfa31f6ebb63470f9660","publication_number":"US8623418B2","cleaned_patent_number":"8623418","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-07","publication_date":"2014-01-07","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} | US8623418B2 | 07 Jan, 2014 | Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 | 07 Nov, 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.