Tasimelteon Global Patent Coverage & Expiry Overview

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It is formulated by 4 pharmaceutical companies such as VANDA PHARMS INC, TEVA PHARMS USA INC, APOTEX and others. It is marketed under 3 brand names, including HETLIOZ, HETLIOZ LQ, TASIMELTEON. Available in 2 different strengths, such as 20MG, 4MG/ML, and administered through 2 routes including CAPSULE;ORAL, SUSPENSION;ORAL.

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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

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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":"47771","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US9855241B2","cleaned_patent_number":"9855241","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2018-01-02","legal_status":"Granted"} US9855241B2 02 Jan, 2018 Granted 25 Jan, 2033
{"application_id":"117725","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11918557B2","cleaned_patent_number":"11918557","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2024-03-05","legal_status":"Granted"} US11918557B2 05 Mar, 2024 Granted 25 Jan, 2033
{"application_id":"47775","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10449176B2","cleaned_patent_number":"10449176","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2019-10-22","legal_status":"Granted"} US10449176B2 22 Oct, 2019 Granted 25 Jan, 2033
{"application_id":"164398","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US12201604B2","cleaned_patent_number":"12201604","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2025-01-21","legal_status":"Granted"} US12201604B2 21 Jan, 2025 Granted 25 Jan, 2033
{"application_id":"47768","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US9060995B2","cleaned_patent_number":"9060995","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2015-06-23","legal_status":"Granted"} US9060995B2 23 Jun, 2015 Granted 25 Jan, 2033
{"application_id":"47776","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10610510B2","cleaned_patent_number":"10610510","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2020-04-07","legal_status":"Granted"} US10610510B2 07 Apr, 2020 Granted 25 Jan, 2033
{"application_id":"47790","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11850229B2","cleaned_patent_number":"11850229","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2023-12-26","legal_status":"Granted"} US11850229B2 26 Dec, 2023 Granted 25 Jan, 2033
{"application_id":"47773","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10149829B2","cleaned_patent_number":"10149829","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2018-12-11","legal_status":"Patented case"} US10149829B2 11 Dec, 2018 Patented case 25 Jan, 2033
{"application_id":"47778","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10945988B2","cleaned_patent_number":"10945988","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2021-03-16","legal_status":"Granted"} US10945988B2 16 Mar, 2021 Granted 25 Jan, 2033
{"application_id":"47779","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10980770B2","cleaned_patent_number":"10980770","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2021-04-20","legal_status":"Granted"} US10980770B2 20 Apr, 2021 Granted 25 Jan, 2033
{"application_id":"47788","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11833130B2","cleaned_patent_number":"11833130","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2023-12-05","legal_status":"Granted"} US11833130B2 05 Dec, 2023 Granted 25 Jan, 2033
{"application_id":"47792","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11826339B2","cleaned_patent_number":"11826339","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2023-11-28","legal_status":"Granted"} US11826339B2 28 Nov, 2023 Granted 25 Jan, 2033
{"application_id":"47769","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US9549913B2","cleaned_patent_number":"9549913","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2017-01-24","legal_status":"Granted"} US9549913B2 24 Jan, 2017 Granted 25 Jan, 2033
{"application_id":"47782","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11285129B2","cleaned_patent_number":"11285129","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2022-03-29","legal_status":"Granted"} US11285129B2 29 Mar, 2022 Granted 25 Jan, 2033
{"application_id":"47772","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"USRE46604E","cleaned_patent_number":"RE46604","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2017-11-14","legal_status":"Patented case"} USRE46604E1 14 Nov, 2017 Patented case 25 Jan, 2033
{"application_id":"47787","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11633377B2","cleaned_patent_number":"11633377","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2023-04-25","legal_status":"Granted"} US11633377B2 25 Apr, 2023 Granted 25 Jan, 2033
{"application_id":"47653","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US9539234B2","cleaned_patent_number":"9539234","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-25","publication_date":"2017-01-10","legal_status":"Granted"} US9539234B2 10 Jan, 2017 Granted 25 Jan, 2033
{"application_id":"47791","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11918556B2","cleaned_patent_number":"11918556","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-04-07","publication_date":"2024-03-05","legal_status":"Granted"} US11918556B2 05 Mar, 2024 Granted 07 Apr, 2033
{"application_id":"47770","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US9730910B2","cleaned_patent_number":"9730910","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-05-17","publication_date":"2017-08-15","legal_status":"Granted"} US9730910B2 15 Aug, 2017 Granted 17 May, 2034
{"application_id":"47789","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11786502B2","cleaned_patent_number":"11786502","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2023-10-17","legal_status":"Granted"} US11786502B2 17 Oct, 2023 Granted 10 Oct, 2034
{"application_id":"47781","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US11141400B2","cleaned_patent_number":"11141400","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2021-10-12","legal_status":"Patented case"} US11141400B2 12 Oct, 2021 Patented case 10 Oct, 2034
{"application_id":"47777","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10610511B2","cleaned_patent_number":"10610511","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-10","publication_date":"2020-04-07","legal_status":"Granted"} US10610511B2 07 Apr, 2020 Granted 10 Oct, 2034
{"application_id":"47864","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"acd01ffe4fe645a29c40","publication_number":"US10071977B2","cleaned_patent_number":"10071977","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-12","publication_date":"2018-09-11","legal_status":"Granted"} US10071977B2 Molecular Formulation 11 Sep, 2018 Granted 12 Feb, 2035
{"application_id":"47858","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"acd01ffe4fe645a29c40","publication_number":"US10829465B2","cleaned_patent_number":"10829465","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-12","publication_date":"2020-11-10","legal_status":"Granted"} US10829465B2 Molecular Formulation 10 Nov, 2020 Granted 12 Feb, 2035
{"application_id":"47867","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"acd01ffe4fe645a29c40","publication_number":"US11566011B2","cleaned_patent_number":"11566011","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-12","publication_date":"2023-01-31","legal_status":"Granted"} US11566011B2 Molecular Formulation 31 Jan, 2023 Granted 12 Feb, 2035
{"application_id":"117098","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"acd01ffe4fe645a29c40","publication_number":"US11760740B2","cleaned_patent_number":"11760740","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-12","publication_date":"2023-09-19","legal_status":"Granted"} US11760740B2 Molecular Formulation 19 Sep, 2023 Granted 12 Feb, 2035
{"application_id":"124160","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"acd01ffe4fe645a29c40","publication_number":"US12049457B2","cleaned_patent_number":"12049457","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-12","publication_date":"2024-07-30","legal_status":"Granted"} US12049457B2 Molecular Formulation 30 Jul, 2024 Granted 12 Feb, 2035
{"application_id":"47774","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"e821e5c2814d4b03bb59","publication_number":"US10376487B2","cleaned_patent_number":"10376487","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-07-27","publication_date":"2019-08-13","legal_status":"Patented case"} US10376487B2 13 Aug, 2019 Patented case 27 Jul, 2035
{"application_id":"47852","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"79ad53cb79b746c7b672","publication_number":"US11266622B2","cleaned_patent_number":"11266622","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-08-29","publication_date":"2022-03-08","legal_status":"Granted"} US11266622B2 08 Mar, 2022 Granted 29 Aug, 2035
{"application_id":"47837","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"79ad53cb79b746c7b672","publication_number":"US10179119B2","cleaned_patent_number":"10179119","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-08-29","publication_date":"2019-01-15","legal_status":"Granted"} US10179119B2 15 Jan, 2019 Granted 29 Aug, 2035
{"application_id":"83033","ingredient":"TASIMELTEON","trade_name":"HETLIOZ LQ","family_id":"ac718a17c76b419399b7","publication_number":"US11202770B2","cleaned_patent_number":"11202770","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-11","publication_date":"2021-12-21","legal_status":"Granted"} US11202770B2 Formulation 21 Dec, 2021 Granted 11 Dec, 2040
{"application_id":"83039","ingredient":"TASIMELTEON","trade_name":"HETLIOZ","family_id":"a9a007af0db4435288d6","publication_number":"US11759446B2","cleaned_patent_number":"11759446","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-21","publication_date":"2023-09-19","legal_status":"Granted"} US11759446B2 19 Sep, 2023 Granted 21 Feb, 2041

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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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