Exenatide Synthetic Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as ASTRAZENECA AB, AMNEAL. It is marketed under 4 brand names, including BYDUREON, BYDUREON PEN, BYDUREON BCISE and others. Available in 5 different strengths, such as 2MG/VIAL, 2MG, 2MG/0.85ML (2MG/0.85ML) and others, and administered through 3 routes including FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS, SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS, INJECTABLE;SUBCUTANEOUS.

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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":"39968","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"914c5084e73143e7a5df","publication_number":"US8431685B2","cleaned_patent_number":"8431685","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-13","publication_date":"2013-04-30","legal_status":"Patented case"} US8431685B2 30 Apr, 2013 Patented case 13 Oct, 2025
{"application_id":"39966","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"914c5084e73143e7a5df","publication_number":"US7612176B2","cleaned_patent_number":"7612176","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-13","publication_date":"2009-11-03","legal_status":"Patented case"} US7612176B2 03 Nov, 2009 Patented case 13 Oct, 2025
{"application_id":"39969","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"914c5084e73143e7a5df","publication_number":"US8461105B2","cleaned_patent_number":"8461105","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-13","publication_date":"2013-06-11","legal_status":"Patented case"} US8461105B2 11 Jun, 2013 Patented case 13 Oct, 2025
{"application_id":"39931","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"914c5084e73143e7a5df","publication_number":"US7456254B2","cleaned_patent_number":"7456254","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-30","publication_date":"2008-11-25","legal_status":"Patented case"} US7456254B2 25 Nov, 2008 Patented case 30 Dec, 2025
{"application_id":"1315","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"16d27eafce1142e3979e","publication_number":"US6515117B2","cleaned_patent_number":"6515117","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-04","publication_date":"2003-02-04","legal_status":"Patented case"} US6515117B2 04 Feb, 2003 Patented case 04 Apr, 2026
{"application_id":"129376","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"658139e8eacc45fc8056","publication_number":"US8329648B2","cleaned_patent_number":"8329648","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-18","publication_date":"2012-12-11","legal_status":"Patented case"} US8329648B2 11 Dec, 2012 Patented case 18 Feb, 2027
{"application_id":"129378","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"658139e8eacc45fc8056","publication_number":"US8906851B2","cleaned_patent_number":"8906851","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-18","publication_date":"2014-12-09","legal_status":"Patented case"} US8906851B2 09 Dec, 2014 Patented case 18 Feb, 2027
{"application_id":"129379","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"658139e8eacc45fc8056","publication_number":"US9884092B2","cleaned_patent_number":"9884092","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-18","publication_date":"2018-02-06","legal_status":"Patented case"} US9884092B2 06 Feb, 2018 Patented case 18 Feb, 2027
{"application_id":"1322","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"4b7ba1cd2cc042648767","publication_number":"US8501698B2","cleaned_patent_number":"8501698","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-20","publication_date":"2013-08-06","legal_status":"Patented case"} US8501698B2 06 Aug, 2013 Patented case 20 Dec, 2027
{"application_id":"129370","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON","family_id":"0844ff11d6e64e509841","publication_number":"US8361972B2","cleaned_patent_number":"8361972","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2013-01-29","legal_status":"Granted"} US8361972B2 29 Jan, 2013 Granted 21 Sep, 2028
{"application_id":"41713","ingredient":"EXENATIDE SYNTHETIC","trade_name":"BYDUREON BCISE","family_id":"52fde6cbec5347b5bf5d","publication_number":"US8895033B2","cleaned_patent_number":"8895033","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-04","publication_date":"2014-11-25","legal_status":"Granted"} US8895033B2 25 Nov, 2014 Granted 04 Apr, 2031

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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