NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as COLLEGIUM PHARM INC. It is marketed under 2 brand names, including NUCYNTA ER, NUCYNTA. Available in 6 different strengths, such as EQ 50MG BASE, EQ 100MG BASE, EQ 150MG BASE and others, and administered through 2 routes including TABLET, EXTENDED RELEASE;ORAL, SOLUTION;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 | |
|---|---|---|---|---|---|
| {"application_id":"76624","ingredient":"TAPENTADOL HYDROCHLORIDE","trade_name":"NUCYNTA","family_id":"79a28420ee6b47de81f8","publication_number":"US7994364B2","cleaned_patent_number":"7994364","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-27","publication_date":"2011-08-09","legal_status":"Granted"} | US7994364B2 | 09 Aug, 2011 | Granted | 27 Dec, 2025 | |
| {"application_id":"27263","ingredient":"TAPENTADOL HYDROCHLORIDE","trade_name":"NUCYNTA ER","family_id":"40f4f2033dff4ce1988d","publication_number":"US11344512B2","cleaned_patent_number":"11344512","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-10-21","publication_date":"2022-05-31","legal_status":"Granted"} | US11344512B2 | 31 May, 2022 | Granted | 21 Oct, 2028 | |
| {"application_id":"86707","ingredient":"TAPENTADOL HYDROCHLORIDE","trade_name":"NUCYNTA ER","family_id":"b638c7a4d0cd478a8b7c","publication_number":"US8536130B2","cleaned_patent_number":"8536130","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-22","publication_date":"2013-09-17","legal_status":"Granted"} | US8536130B2 | 17 Sep, 2013 | Granted | 22 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.