NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as TAKEDA PHARMS USA, ENDO OPERATIONS, TWI PHARMS and others. It is marketed under 2 brand names, including DEXILANT SOLUTAB, DEXLANSOPRAZOLE. Available in 2 different strengths, such as 30MG, 60MG, and administered through 2 routes including TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL, CAPSULE, DELAYED RELEASE;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":"43659","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"afcf1bd3483345fc91a5","publication_number":"US9238029B2","cleaned_patent_number":"9238029","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-17","publication_date":"2016-01-19","legal_status":"Granted"} | US9238029B2 Formulation | 19 Jan, 2016 | Granted | 17 Jan, 2026 | |
| {"application_id":"43646","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"17cb22f8c9dd438ebfe8","publication_number":"US9011926B2","cleaned_patent_number":"9011926","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-02-24","publication_date":"2015-04-21","legal_status":"Granted"} | US9011926B2 Formulation | 21 Apr, 2015 | Granted | 24 Feb, 2026 | |
| {"application_id":"43665","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"afcf1bd3483345fc91a5","publication_number":"US8461187B2","cleaned_patent_number":"8461187","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-17","publication_date":"2013-06-11","legal_status":"Granted"} | US8461187B2 | 11 Jun, 2013 | Granted | 17 Jul, 2026 | |
| {"application_id":"43719","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"d11e7a557e434540b2e3","publication_number":"US7790755B2","cleaned_patent_number":"7790755","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-02","publication_date":"2010-09-07","legal_status":"Granted"} | US7790755B2 | 07 Sep, 2010 | Granted | 02 Feb, 2027 | |
| {"application_id":"43786","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"2391d27b482e4647b1c0","publication_number":"US8105626B2","cleaned_patent_number":"8105626","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-27","publication_date":"2012-01-31","legal_status":"Granted"} | US8105626B2 | 31 Jan, 2012 | Granted | 27 Mar, 2027 | |
| {"application_id":"43655","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"17cb22f8c9dd438ebfe8","publication_number":"US8871273B2","cleaned_patent_number":"8871273","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-11","publication_date":"2014-10-28","legal_status":"Granted"} | US8871273B2 | 28 Oct, 2014 | Granted | 11 Jul, 2028 | |
| {"application_id":"88617","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT SOLUTAB","family_id":"d7c9b733b2c94b6b97cd","publication_number":"US9241910B2","cleaned_patent_number":"9241910","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-10","publication_date":"2016-01-26","legal_status":"Granted"} | US9241910B2 Formulation | 26 Jan, 2016 | Granted | 10 Mar, 2029 | |
| {"application_id":"43803","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"97565d4e76cf4e1390d0","publication_number":"US8173158B2","cleaned_patent_number":"8173158","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-17","publication_date":"2012-05-08","legal_status":"Patented case"} | US8173158B2 | 08 May, 2012 | Patented case | 17 Sep, 2030 | |
| {"application_id":"43642","ingredient":"DEXLANSOPRAZOLE","trade_name":"DEXILANT","family_id":"78fc6f0d8755470190d8","publication_number":"US9233103B2","cleaned_patent_number":"9233103","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-05","publication_date":"2016-01-12","legal_status":"Granted"} | US9233103B2 | 12 Jan, 2016 | Granted | 05 Mar, 2032 |
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.