Topiramate Global Patent Coverage & Expiry Overview

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It is formulated by 28 pharmaceutical companies such as AIPING PHARM INC, SENORES PHARMS, VIVUS LLC and others. It is marketed under 6 brand names, including TOPIRAMATE, QSYMIA, TROKENDI XR and others. Available in 11 different strengths, such as 200MG, 100MG, 50MG and others, and administered through 4 routes including TABLET;ORAL, CAPSULE, EXTENDED RELEASE;ORAL, SOLUTION;ORAL and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"44947","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US9622983B2","cleaned_patent_number":"9622983","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2017-04-18","legal_status":"Granted"} US9622983B2 Formulation 18 Apr, 2017 Granted 16 Nov, 2027
{"application_id":"44958","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8298580B2","cleaned_patent_number":"8298580","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2012-10-30","legal_status":"Granted"} US8298580B2 Formulation 30 Oct, 2012 Granted 16 Nov, 2027
{"application_id":"44959","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8663683B2","cleaned_patent_number":"8663683","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2014-03-04","legal_status":"Granted"} US8663683B2 Formulation 04 Mar, 2014 Granted 16 Nov, 2027
{"application_id":"44960","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8877248B1","cleaned_patent_number":"8877248","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2014-11-04","legal_status":"Patented case"} US8877248B2 Formulation 04 Nov, 2014 Patented case 16 Nov, 2027
{"application_id":"44961","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8889191B2","cleaned_patent_number":"8889191","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2014-11-18","legal_status":"Granted"} US8889191B2 18 Nov, 2014 Granted 16 Nov, 2027
{"application_id":"44962","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8992989B2","cleaned_patent_number":"8992989","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2015-03-31","legal_status":"Granted"} US8992989B2 Formulation 31 Mar, 2015 Granted 16 Nov, 2027
{"application_id":"44963","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US9549940B2","cleaned_patent_number":"9549940","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2017-01-24","legal_status":"Patented case"} US9549940B2 Formulation 24 Jan, 2017 Patented case 16 Nov, 2027
{"application_id":"44964","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US9555004B2","cleaned_patent_number":"9555004","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2017-01-31","legal_status":"Granted"} US9555004B2 Formulation 31 Jan, 2017 Granted 16 Nov, 2027
{"application_id":"44965","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US10314790B2","cleaned_patent_number":"10314790","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-16","publication_date":"2019-06-11","legal_status":"Granted"} US10314790B2 Formulation 11 Jun, 2019 Granted 16 Nov, 2027
{"application_id":"44957","ingredient":"TOPIRAMATE","trade_name":"TROKENDI XR","family_id":"82b9d3b4e2fb424aaa47","publication_number":"US8298576B2","cleaned_patent_number":"8298576","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-04","publication_date":"2012-10-30","legal_status":"Granted"} US8298576B2 Formulation 30 Oct, 2012 Granted 04 Apr, 2028
{"application_id":"44712","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8895057B2","cleaned_patent_number":"8895057","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2014-11-25","legal_status":"Granted"} US8895057B2 25 Nov, 2014 Granted 09 Jun, 2028
{"application_id":"44747","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8895058B2","cleaned_patent_number":"8895058","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2014-11-25","legal_status":"Granted"} US8895058B2 Formulation 25 Nov, 2014 Granted 09 Jun, 2028
{"application_id":"44748","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US9011905B2","cleaned_patent_number":"9011905","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2015-04-21","legal_status":"Granted"} US9011905B2 Formulation 21 Apr, 2015 Granted 09 Jun, 2028
{"application_id":"44749","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US9011906B2","cleaned_patent_number":"9011906","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2015-04-21","legal_status":"Granted"} US9011906B2 21 Apr, 2015 Granted 09 Jun, 2028
{"application_id":"44745","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8580298B2","cleaned_patent_number":"8580298","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-15","publication_date":"2013-11-12","legal_status":"Granted"} US8580298B2 Formulation 12 Nov, 2013 Granted 15 May, 2029
{"application_id":"44746","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8580299B2","cleaned_patent_number":"8580299","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-14","publication_date":"2013-11-12","legal_status":"Granted"} US8580299B2 12 Nov, 2013 Granted 14 Jun, 2029
{"application_id":"44778","ingredient":"TOPIRAMATE","trade_name":"QUDEXY XR","family_id":"623aadee434347c2b2c0","publication_number":"US8889190B2","cleaned_patent_number":"8889190","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-19","publication_date":"2014-11-18","legal_status":"Patented case"} US8889190B2 Formulation 18 Nov, 2014 Patented case 19 Mar, 2033
{"application_id":"44777","ingredient":"TOPIRAMATE","trade_name":"QUDEXY XR","family_id":"623aadee434347c2b2c0","publication_number":"US8652527B1","cleaned_patent_number":"8652527","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-19","publication_date":"2014-02-18","legal_status":"Granted"} US8652527B2 Formulation 18 Feb, 2014 Granted 19 Mar, 2033
{"application_id":"44768","ingredient":"TOPIRAMATE","trade_name":"QUDEXY XR","family_id":"623aadee434347c2b2c0","publication_number":"US10363224B2","cleaned_patent_number":"10363224","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-19","publication_date":"2019-07-30","legal_status":"Granted"} US10363224B2 30 Jul, 2019 Granted 19 Mar, 2033
{"application_id":"44779","ingredient":"TOPIRAMATE","trade_name":"QUDEXY XR","family_id":"623aadee434347c2b2c0","publication_number":"US9101545B2","cleaned_patent_number":"9101545","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-19","publication_date":"2015-08-11","legal_status":"Patented case"} US9101545B2 Formulation 11 Aug, 2015 Patented case 19 Mar, 2033
{"application_id":"44780","ingredient":"TOPIRAMATE","trade_name":"QUDEXY XR","family_id":"623aadee434347c2b2c0","publication_number":"US9555005B2","cleaned_patent_number":"9555005","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-19","publication_date":"2017-01-31","legal_status":"Granted"} US9555005B2 Formulation 31 Jan, 2017 Granted 19 Mar, 2033
{"application_id":"120873","ingredient":"TOPIRAMATE","trade_name":"EPRONTIA","family_id":"cac090b2c5b34160bc6a","publication_number":"US11826343B2","cleaned_patent_number":"11826343","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-21","publication_date":"2023-11-28","legal_status":"Granted"} US11826343B2 Formulation 28 Nov, 2023 Granted 21 Aug, 2040
{"application_id":"120874","ingredient":"TOPIRAMATE","trade_name":"EPRONTIA","family_id":"cac090b2c5b34160bc6a","publication_number":"US11911362B2","cleaned_patent_number":"11911362","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-21","publication_date":"2024-02-27","legal_status":"Granted"} US11911362B2 Formulation 27 Feb, 2024 Granted 21 Aug, 2040
{"application_id":"242134","ingredient":"TOPIRAMATE","trade_name":"EPRONTIA","family_id":"","publication_number":"US12290503B2","cleaned_patent_number":"12290503","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-21","publication_date":"2025-05-06","legal_status":"Granted"} US12290503B2 Formulation 06 May, 2025 Granted 21 Aug, 2040
{"application_id":"108110","ingredient":"TOPIRAMATE","trade_name":"EPRONTIA","family_id":"7d8d8731700b48ad9387","publication_number":"US11433046B2","cleaned_patent_number":"11433046","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-21","publication_date":"2022-09-06","legal_status":"Granted"} US11433046B2 06 Sep, 2022 Granted 21 Aug, 2040
{"application_id":"112688","ingredient":"TOPIRAMATE","trade_name":"EPRONTIA","family_id":"dfda40f5568a4c5b8843","publication_number":"US11633374B2","cleaned_patent_number":"11633374","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-21","publication_date":"2023-04-25","legal_status":"Granted"} US11633374B2 Formulation 25 Apr, 2023 Granted 21 Aug, 2040

Recent Clinical Trials

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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.

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