Amphetamine Sulfate Global Patent Coverage & Expiry Overview

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It is formulated by 43 pharmaceutical companies such as AZURITY, ACTAVIS ELIZABETH, BARR LABS INC and others. It is marketed under 12 brand names, including DEXTROAMPHETAMINE SULFATE, DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, EVEKEO and others. Available in 23 different strengths, such as 30MG, 2.5MG, 5MG and others, and administered through 6 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":"44519","ingredient":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","trade_name":"MYDAYIS","family_id":"750d7da82dbe4f9f87a4","publication_number":"US9173857B2","cleaned_patent_number":"9173857","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-12","publication_date":"2015-11-03","legal_status":"Granted"} US9173857B2 03 Nov, 2015 Granted 12 May, 2026
{"application_id":"57921","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR 10","family_id":"ab746e06a067453e8066","publication_number":"US9675704B2","cleaned_patent_number":"9675704","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2017-06-13","legal_status":"Granted"} US9675704B2 Formulation 13 Jun, 2017 Granted 15 Mar, 2027
{"application_id":"57911","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR 10","family_id":"ab746e06a067453e8066","publication_number":"US8337890B2","cleaned_patent_number":"8337890","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2012-12-25","legal_status":"Granted"} US8337890B2 Formulation 25 Dec, 2012 Granted 15 Mar, 2027
{"application_id":"57913","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US8597684B2","cleaned_patent_number":"8597684","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2013-12-03","legal_status":"Granted"} US8597684B2 Formulation 03 Dec, 2013 Granted 15 Mar, 2027
{"application_id":"57914","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US8747902B2","cleaned_patent_number":"8747902","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2014-06-10","legal_status":"Granted"} US8747902B2 Formulation 10 Jun, 2014 Granted 15 Mar, 2027
{"application_id":"57916","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US8883217B2","cleaned_patent_number":"8883217","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2014-11-11","legal_status":"Granted"} US8883217B2 Formulation 11 Nov, 2014 Granted 15 Mar, 2027
{"application_id":"57920","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US9675703B2","cleaned_patent_number":"9675703","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2017-06-13","legal_status":"Granted"} US9675703B2 Formulation 13 Jun, 2017 Granted 15 Mar, 2027
{"application_id":"57922","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US10086087B2","cleaned_patent_number":"10086087","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-15","publication_date":"2018-10-02","legal_status":"Granted"} US10086087B2 Formulation 02 Oct, 2018 Granted 15 Mar, 2027
{"application_id":"57892","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"ab746e06a067453e8066","publication_number":"US8062667B2","cleaned_patent_number":"8062667","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-29","publication_date":"2011-11-22","legal_status":"Granted"} US8062667B2 Formulation 22 Nov, 2011 Granted 29 Mar, 2029
{"application_id":"44520","ingredient":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","trade_name":"MYDAYIS","family_id":"750d7da82dbe4f9f87a4","publication_number":"US8846100B2","cleaned_patent_number":"8846100","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-24","publication_date":"2014-09-30","legal_status":"Granted"} US8846100B2 Formulation 30 Sep, 2014 Granted 24 Aug, 2029
{"application_id":"111319","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR","family_id":"","publication_number":"US11590228B1","cleaned_patent_number":"11590228","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-07","publication_date":"2023-02-28","legal_status":"Granted"} US11590228B2 Formulation 28 Feb, 2023 Granted 07 Sep, 2036
{"application_id":"88731","ingredient":"AMPHETAMINE SULFATE","trade_name":"EVEKEO ODT","family_id":"634d819f55c142bc884d","publication_number":"US11896562B2","cleaned_patent_number":"11896562","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-03-10","publication_date":"2024-02-13","legal_status":"Patented case"} US11896562B2 13 Feb, 2024 Patented case 10 Mar, 2037
{"application_id":"88729","ingredient":"AMPHETAMINE SULFATE","trade_name":"EVEKEO ODT","family_id":"634d819f55c142bc884d","publication_number":"US11160772B2","cleaned_patent_number":"11160772","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-03-10","publication_date":"2021-11-02","legal_status":"Patented case"} US11160772B2 Formulation 02 Nov, 2021 Patented case 10 Mar, 2037
{"application_id":"88728","ingredient":"AMPHETAMINE SULFATE","trade_name":"EVEKEO ODT","family_id":"634d819f55c142bc884d","publication_number":"US10441554B2","cleaned_patent_number":"10441554","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-03-10","publication_date":"2019-10-15","legal_status":"Patented case"} US10441554B2 Formulation 15 Oct, 2019 Patented case 10 Mar, 2037
{"application_id":"111325","ingredient":"AMPHETAMINE; AMPHETAMINE ASPARTATE\/DEXTROAMPHETAMINE SULFATE","trade_name":"DYANAVEL XR 10","family_id":"","publication_number":"US11590081B1","cleaned_patent_number":"11590081","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-24","publication_date":"2023-02-28","legal_status":"Granted"} US11590081B2 Formulation 28 Feb, 2023 Granted 24 Sep, 2038

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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