NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 20 pharmaceutical companies such as ENDO OPERATIONS, OYSTER POINT PHARMA, APOTEX and others. It is marketed under 2 brand names, including VARENICLINE TARTRATE, TYRVAYA. Available in 3 different strengths, such as EQ 1MG BASE, EQ 0.5MG BASE, EQ 0.03MG BASE/SPRAY, and administered through 2 routes including TABLET;ORAL, SPRAY;NASAL.
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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":"75851","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US10456396B2","cleaned_patent_number":"10456396","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2019-10-29","legal_status":"Granted"} | US10456396B2 Formulation | 29 Oct, 2019 | Granted | 19 Oct, 2035 | |
| {"application_id":"75823","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US11224598B2","cleaned_patent_number":"11224598","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2022-01-18","legal_status":"Granted"} | US11224598B2 | 18 Jan, 2022 | Granted | 19 Oct, 2035 | |
| {"application_id":"75852","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US11903941B2","cleaned_patent_number":"11903941","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2024-02-20","legal_status":"Granted"} | US11903941B2 | 20 Feb, 2024 | Granted | 19 Oct, 2035 | |
| {"application_id":"122908","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"","publication_number":"US11903942B2","cleaned_patent_number":"11903942","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2024-02-20","legal_status":"Granted"} | US11903942B2 Formulation | 20 Feb, 2024 | Granted | 19 Oct, 2035 | |
| {"application_id":"122907","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"","publication_number":"US11903943B2","cleaned_patent_number":"11903943","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2024-02-20","legal_status":"Granted"} | US11903943B2 | 20 Feb, 2024 | Granted | 19 Oct, 2035 | |
| {"application_id":"122906","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"","publication_number":"US11911380B2","cleaned_patent_number":"11911380","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2024-02-27","legal_status":"Granted"} | US11911380B2 | 27 Feb, 2024 | Granted | 19 Oct, 2035 | |
| {"application_id":"75847","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US9504644B2","cleaned_patent_number":"9504644","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2016-11-29","legal_status":"Granted"} | US9504644B2 | 29 Nov, 2016 | Granted | 19 Oct, 2035 | |
| {"application_id":"75848","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US9504645B2","cleaned_patent_number":"9504645","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2016-11-29","legal_status":"Granted"} | US9504645B2 Formulation | 29 Nov, 2016 | Granted | 19 Oct, 2035 | |
| {"application_id":"75849","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US9532944B2","cleaned_patent_number":"9532944","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2017-01-03","legal_status":"Granted"} | US9532944B2 | 03 Jan, 2017 | Granted | 19 Oct, 2035 | |
| {"application_id":"75850","ingredient":"VARENICLINE TARTRATE","trade_name":"TYRVAYA","family_id":"75b490dbe6d94c5c8228","publication_number":"US9597284B2","cleaned_patent_number":"9597284","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-19","publication_date":"2017-03-21","legal_status":"Granted"} | US9597284B2 | 21 Mar, 2017 | Granted | 19 Oct, 2035 |
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.