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 | |
|---|---|---|---|---|---|
| {"application_id":"83559","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8301238B2","cleaned_patent_number":"8301238","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-30","publication_date":"2012-10-30","legal_status":"Expired"} | US8301238B2 Formulation | 30 Oct, 2012 | Expired | 30 Sep, 2031 | |
| {"application_id":"83563","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9364656B2","cleaned_patent_number":"9364656","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-30","publication_date":"2016-06-14","legal_status":"Expired"} | US9364656B2 | 14 Jun, 2016 | Expired | 30 Sep, 2031 | |
| {"application_id":"83565","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9731121B2","cleaned_patent_number":"9731121","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-17","publication_date":"2017-08-15","legal_status":"Expired"} | US9731121B2 Formulation | 15 Aug, 2017 | Expired | 17 Oct, 2031 | |
| {"application_id":"83561","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8781571B2","cleaned_patent_number":"8781571","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-31","publication_date":"2014-07-15","legal_status":"Expired"} | US8781571B2 Formulation | 15 Jul, 2014 | Expired | 31 Mar, 2032 | |
| {"application_id":"83560","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8428708B1","cleaned_patent_number":"8428708","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-21","publication_date":"2013-04-23","legal_status":"Expired"} | US8428708B2 | 23 Apr, 2013 | Expired | 21 May, 2032 | |
| {"application_id":"83487","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8428709B1","cleaned_patent_number":"8428709","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-11","publication_date":"2013-04-23","legal_status":"Expired"} | US8428709B2 Formulation | 23 Apr, 2013 | Expired | 11 Jun, 2032 | |
| {"application_id":"83562","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9095706B2","cleaned_patent_number":"9095706","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-03","publication_date":"2015-08-04","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} | US9095706B2 Formulation | 04 Aug, 2015 | Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 | 03 Feb, 2033 |
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.