Deutetrabenazine Global Patent Coverage & Expiry Overview

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It is formulated by 3 pharmaceutical companies such as TEVA BRANDED PHARM, TEVA, AUROBINDO PHARMA LTD. It is marketed under 3 brand names, including AUSTEDO, AUSTEDO XR, DEUTETRABENAZINE. Available in 9 different strengths, such as 6MG, 9MG, 12MG and others, and administered through 2 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL.

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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":"90437","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"480e753128c74cd0b6b0","publication_number":"US8524733B2","cleaned_patent_number":"8524733","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-03","publication_date":"2013-09-03","legal_status":"Granted"} US8524733B2 03 Sep, 2013 Granted 03 Oct, 2031
{"application_id":"7336","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"4c4e821d2ba043c4ae9e","publication_number":"US9814708B2","cleaned_patent_number":"9814708","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-18","publication_date":"2017-11-14","legal_status":"Granted"} US9814708B2 14 Nov, 2017 Granted 18 Mar, 2034
{"application_id":"36374","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"4c4e821d2ba043c4ae9e","publication_number":"US11666566B2","cleaned_patent_number":"11666566","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-18","publication_date":"2023-06-06","legal_status":"Granted"} US11666566B2 06 Jun, 2023 Granted 18 Mar, 2034
{"application_id":"36366","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"4c4e821d2ba043c4ae9e","publication_number":"US9233959B2","cleaned_patent_number":"9233959","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-18","publication_date":"2016-01-12","legal_status":"Granted"} US9233959B2 12 Jan, 2016 Granted 18 Mar, 2034
{"application_id":"36368","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"4c4e821d2ba043c4ae9e","publication_number":"US9296739B2","cleaned_patent_number":"9296739","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-18","publication_date":"2016-03-29","legal_status":"Granted"} US9296739B2 29 Mar, 2016 Granted 18 Mar, 2034
{"application_id":"7337","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"4c4e821d2ba043c4ae9e","publication_number":"US9550780B2","cleaned_patent_number":"9550780","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-18","publication_date":"2017-01-24","legal_status":"Granted"} US9550780B2 24 Jan, 2017 Granted 18 Mar, 2034
{"application_id":"38246","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US11648244B2","cleaned_patent_number":"11648244","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2023-05-16","legal_status":"Patented case"} US11648244B2 16 May, 2023 Patented case 07 Sep, 2036
{"application_id":"38243","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US10959996B2","cleaned_patent_number":"10959996","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2021-03-30","legal_status":"Granted"} US10959996B2 30 Mar, 2021 Granted 07 Sep, 2036
{"application_id":"38242","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US11357772B2","cleaned_patent_number":"11357772","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2022-06-14","legal_status":"Granted"} US11357772B2 14 Jun, 2022 Granted 07 Sep, 2036
{"application_id":"38248","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US11446291B2","cleaned_patent_number":"11446291","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2022-09-20","legal_status":"Granted"} US11446291B2 20 Sep, 2022 Granted 07 Sep, 2036
{"application_id":"38247","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US11564917B2","cleaned_patent_number":"11564917","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2023-01-31","legal_status":"Granted"} US11564917B2 31 Jan, 2023 Granted 07 Sep, 2036
{"application_id":"38249","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"19408b94a4ed4fc0a3ed","publication_number":"US12016858B2","cleaned_patent_number":"12016858","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2024-06-25","legal_status":"Granted"} US12016858B2 25 Jun, 2024 Granted 07 Sep, 2036
{"application_id":"90502","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"76259a6438fc4d189d9a","publication_number":"US11813232B2","cleaned_patent_number":"11813232","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-15","publication_date":"2023-11-14","legal_status":"Granted"} US11813232B2 14 Nov, 2023 Granted 15 Sep, 2038
{"application_id":"90484","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO","family_id":"76259a6438fc4d189d9a","publication_number":"US11179386B2","cleaned_patent_number":"11179386","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-15","publication_date":"2021-11-23","legal_status":"Granted"} US11179386B2 23 Nov, 2021 Granted 15 Sep, 2038
{"application_id":"111323","ingredient":"DEUTETRABENAZINE","trade_name":"AUSTEDO XR","family_id":"","publication_number":"US11311488B2","cleaned_patent_number":"11311488","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-06-10","publication_date":"2022-04-26","legal_status":"Granted"} US11311488B2 Formulation 26 Apr, 2022 Granted 10 Jun, 2041

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

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.

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