Octreotide Acetate Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 9 pharmaceutical companies such as MYLAN INSTITUTIONAL, WOCKHARDT USA, SAGENT PHARMS INC and others. It is marketed under 5 brand names, including OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE, OCTREOTIDE ACETATE PRESERVATIVE FREE and others. Available in 10 different strengths, such as EQ 0.05MG BASE/ML, EQ 0.5MG BASE/ML, EQ 0.1MG BASE/ML and others, and administered through 3 routes including INJECTABLE;INJECTION, CAPSULE, DELAYED RELEASE;ORAL, SOLUTION;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":"118568","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US8329198B2","cleaned_patent_number":"8329198","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2012-12-11","legal_status":"Granted"} US8329198B2 Formulation 11 Dec, 2012 Granted 17 Sep, 2029
{"application_id":"118563","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US9566246B2","cleaned_patent_number":"9566246","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2017-02-14","legal_status":"Granted"} US9566246B2 Formulation 14 Feb, 2017 Granted 17 Sep, 2029
{"application_id":"43888","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US9265812B2","cleaned_patent_number":"9265812","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2016-02-23","legal_status":"Granted"} US9265812B2 Formulation 23 Feb, 2016 Granted 17 Sep, 2029
{"application_id":"114082","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US11986529B2","cleaned_patent_number":"11986529","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2024-05-21","legal_status":"Granted"} US11986529B2 21 May, 2024 Granted 17 Sep, 2029
{"application_id":"43845","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US8535695B2","cleaned_patent_number":"8535695","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2013-09-17","legal_status":"Granted"} US8535695B2 17 Sep, 2013 Granted 17 Sep, 2029
{"application_id":"114081","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"31a54674ed484b38b12c","publication_number":"US11969471B2","cleaned_patent_number":"11969471","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-17","publication_date":"2024-04-30","legal_status":"Granted"} US11969471B2 Formulation 30 Apr, 2024 Granted 17 Sep, 2029
{"application_id":"43840","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US11857595B2","cleaned_patent_number":"11857595","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2024-01-02","legal_status":"Patented case"} US11857595B2 02 Jan, 2024 Patented case 03 Feb, 2036
{"application_id":"43828","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US10695397B2","cleaned_patent_number":"10695397","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2020-06-30","legal_status":"Granted"} US10695397B2 30 Jun, 2020 Granted 03 Feb, 2036
{"application_id":"118557","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US11052126B2","cleaned_patent_number":"11052126","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2021-07-06","legal_status":"Granted"} US11052126B2 06 Jul, 2021 Granted 03 Feb, 2036
{"application_id":"118559","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US11338011B2","cleaned_patent_number":"11338011","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2022-05-24","legal_status":"Granted"} US11338011B2 24 May, 2022 Granted 03 Feb, 2036
{"application_id":"109657","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US11510963B2","cleaned_patent_number":"11510963","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2022-11-29","legal_status":"Granted"} US11510963B2 29 Nov, 2022 Granted 03 Feb, 2036
{"application_id":"43837","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US10238709B2","cleaned_patent_number":"10238709","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2019-03-26","legal_status":"Granted"} US10238709B2 26 Mar, 2019 Granted 03 Feb, 2036
{"application_id":"121656","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US20240245748A1","cleaned_patent_number":"12246054","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2025-03-11","legal_status":"Granted"} US12246054B2 11 Mar, 2025 Granted 03 Feb, 2036
{"application_id":"121655","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"d50e421e19f8458ea967","publication_number":"US20240245749A1","cleaned_patent_number":"12251418","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-02-03","publication_date":"2025-03-18","legal_status":"Pending"} US12251418B2 18 Mar, 2025 Pending 03 Feb, 2036
{"application_id":"125721","ingredient":"OCTREOTIDE ACETATE","trade_name":"BYNFEZIA PEN","family_id":"","publication_number":"US10342850B2","cleaned_patent_number":"10342850","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-05-15","publication_date":"2019-07-09","legal_status":"Granted"} US10342850B2 Formulation 09 Jul, 2019 Granted 15 May, 2038
{"application_id":"138503","ingredient":"OCTREOTIDE ACETATE","trade_name":"BYNFEZIA PEN","family_id":"","publication_number":"US11052196B1","cleaned_patent_number":"11052196","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-11-03","publication_date":"2021-07-06","legal_status":"Granted"} US11052196B2 06 Jul, 2021 Granted 03 Nov, 2040
{"application_id":"138501","ingredient":"OCTREOTIDE ACETATE","trade_name":"BYNFEZIA PEN","family_id":"","publication_number":"US11246991B1","cleaned_patent_number":"11246991","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-11-03","publication_date":"2022-02-15","legal_status":"Granted"} US11246991B2 15 Feb, 2022 Granted 03 Nov, 2040
{"application_id":"138502","ingredient":"OCTREOTIDE ACETATE","trade_name":"BYNFEZIA PEN","family_id":"","publication_number":"US11534553B2","cleaned_patent_number":"11534553","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-11-03","publication_date":"2022-12-27","legal_status":"Granted"} US11534553B2 27 Dec, 2022 Granted 03 Nov, 2040
{"application_id":"118561","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"7d647fe9ba0140ac9e09","publication_number":"US11141457B1","cleaned_patent_number":"11141457","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-28","publication_date":"2021-10-12","legal_status":"Granted"} US11141457B2 12 Oct, 2021 Granted 28 Dec, 2040
{"application_id":"43827","ingredient":"OCTREOTIDE ACETATE","trade_name":"MYCAPSSA","family_id":"7d647fe9ba0140ac9e09","publication_number":"US11890316B2","cleaned_patent_number":"11890316","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-28","publication_date":"2024-02-06","legal_status":"Granted"} US11890316B2 06 Feb, 2024 Granted 28 Dec, 2040

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

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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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