NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 8 pharmaceutical companies such as WATSON LABS, SENTYNL THERAPS INC, BTCP PHARMA and others. It is marketed under 4 brand names, including FENTANYL CITRATE, ABSTRAL, LAZANDA and others. Available in 10 different strengths, such as EQ 0.1MG BASE, EQ 0.8MG BASE, EQ 0.6MG BASE and others, and administered through 5 routes including TABLET;BUCCAL, SUBLINGUAL, TABLET;SUBLINGUAL, SPRAY, METERED;NASAL and others.
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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":"56357","ingredient":"FENTANYL CITRATE","trade_name":"ONSOLIS","family_id":"663bc864f0f1458588d0","publication_number":"US9597288B2","cleaned_patent_number":"9597288","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-23","publication_date":"2017-03-21","legal_status":"Patented case"} | US9597288B2 Formulation | 21 Mar, 2017 | Patented case | 23 Jul, 2027 | |
| {"application_id":"89004","ingredient":"FENTANYL CITRATE","trade_name":"FENTORA","family_id":"4f0f41afa6c84018a92b","publication_number":"US7862832B2","cleaned_patent_number":"7862832","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-15","publication_date":"2011-01-04","legal_status":"Granted"} | US7862832B2 Formulation | 04 Jan, 2011 | Granted | 15 Jun, 2028 | |
| {"application_id":"89005","ingredient":"FENTANYL CITRATE","trade_name":"FENTORA","family_id":"4f0f41afa6c84018a92b","publication_number":"US7862833B2","cleaned_patent_number":"7862833","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-15","publication_date":"2011-01-04","legal_status":"Granted"} | US7862833B2 Formulation | 04 Jan, 2011 | Granted | 15 Jun, 2028 | |
| {"application_id":"81121","ingredient":"FENTANYL CITRATE","trade_name":"LAZANDA","family_id":"2661d1f19c2a4760be9e","publication_number":"US9731869B2","cleaned_patent_number":"9731869","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-26","publication_date":"2017-08-15","legal_status":"Granted"} | US9731869B2 Formulation | 15 Aug, 2017 | Granted | 26 Jan, 2032 |
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.