NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 25 pharmaceutical companies such as CIPHER PHARMS INC, NORTHSTAR HLTHCARE, SENORES PHARMS and others. It is marketed under 5 brand names, including CONZIP, TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN and others. Available in 10 different strengths, such as 200MG, 300MG, 100MG and others, and administered through 4 routes including CAPSULE, EXTENDED RELEASE;ORAL, TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL and others.
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Licensing: 25 potential partnersUS Launch window: Loading launch window...
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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":"99032","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US9012440B2","cleaned_patent_number":"9012440","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2015-04-21","legal_status":"Granted"} | US9012440B2 Molecular Formulation | 21 Apr, 2015 | Granted | 19 Apr, 2030 | |
| {"application_id":"99034","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US10245276B2","cleaned_patent_number":"10245276","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2019-04-02","legal_status":"Granted"} | US10245276B2 Molecular Formulation | 02 Apr, 2019 | Granted | 19 Apr, 2030 | |
| {"application_id":"99035","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US10548909B2","cleaned_patent_number":"10548909","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2020-02-04","legal_status":"Patented case"} | US10548909B2 | 04 Feb, 2020 | Patented case | 19 Apr, 2030 | |
| {"application_id":"99039","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US11478488B2","cleaned_patent_number":"11478488","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2022-10-25","legal_status":"Granted"} | US11478488B2 | 25 Oct, 2022 | Granted | 19 Apr, 2030 | |
| {"application_id":"99031","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US8598152B2","cleaned_patent_number":"8598152","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2013-12-03","legal_status":"Patented case"} | US8598152B2 Molecular Formulation | 03 Dec, 2013 | Patented case | 19 Apr, 2030 | |
| {"application_id":"98975","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"2b32254838e840a69ae3","publication_number":"US10238668B2","cleaned_patent_number":"10238668","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2019-03-26","legal_status":"Granted"} | US10238668B2 Molecular Formulation | 26 Mar, 2019 | Granted | 19 Apr, 2030 | |
| {"application_id":"99046","ingredient":"CELECOXIB; TRAMADOL HYDROCHLORIDE","trade_name":"SEGLENTIS","family_id":"08cc48e78e734df9a062","publication_number":"US8846744B2","cleaned_patent_number":"8846744","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-03","publication_date":"2014-09-30","legal_status":"Granted"} | US8846744B2 Formulation | 30 Sep, 2014 | Granted | 03 Jun, 2031 | |
| {"application_id":"76746","ingredient":"TRAMADOL HYDROCHLORIDE","trade_name":"QDOLO","family_id":"d3631400c1004b83bdd1","publication_number":"US11103452B2","cleaned_patent_number":"11103452","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-01","publication_date":"2021-08-31","legal_status":"Granted"} | US11103452B2 Formulation | 31 Aug, 2021 | Granted | 01 Sep, 2040 | |
| {"application_id":"76747","ingredient":"TRAMADOL HYDROCHLORIDE","trade_name":"QDOLO","family_id":"81f1841d90394782825d","publication_number":"US11752103B2","cleaned_patent_number":"11752103","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-01","publication_date":"2023-09-12","legal_status":"Granted"} | US11752103B2 Formulation | 12 Sep, 2023 | Granted | 01 Sep, 2040 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.