Treprostinil Global Patent Coverage & Expiry Overview

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It is formulated by 7 pharmaceutical companies such as UNITED THERAP, SANDOZ, ENDO OPERATIONS and others. It is marketed under 5 brand names, including ORENITRAM, TREPROSTINIL, REMODULIN and others. Available in 26 different strengths, such as EQ 1MG BASE, EQ 0.25MG BASE, EQ 0.125MG BASE and others, and administered through 4 routes including TABLET, EXTENDED RELEASE;ORAL, INJECTABLE;INTRAVENOUS, SUBCUTANEOUS, SOLUTION;INTRAVENOUS, SUBCUTANEOUS 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":"66110","ingredient":"TREPROSTINIL","trade_name":"TYVASO DPI","family_id":"dea709e078864b469e3f","publication_number":"US10130685B2","cleaned_patent_number":"10130685","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-08-23","publication_date":"2018-11-20","legal_status":"Patented case"} US10130685B2 Formulation 20 Nov, 2018 Patented case 23 Aug, 2025
{"application_id":"86976","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"e0a6905a106b4b169ee1","publication_number":"US9393203B2","cleaned_patent_number":"9393203","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-27","publication_date":"2016-07-19","legal_status":"Granted"} US9393203B2 Formulation 19 Jul, 2016 Granted 27 Apr, 2026
{"application_id":"62925","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"527227552b9a488c861d","publication_number":"US7417070B2","cleaned_patent_number":"7417070","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-30","publication_date":"2008-08-26","legal_status":"Granted"} US7417070B2 Molecular 26 Aug, 2008 Granted 30 Jul, 2026
{"application_id":"66227","ingredient":"TREPROSTINIL","trade_name":"TYVASO DPI","family_id":"bad307ec11e54475ad0b","publication_number":"US11357782B2","cleaned_patent_number":"11357782","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-14","publication_date":"2022-06-14","legal_status":"Granted"} US11357782B2 14 Jun, 2022 Granted 14 May, 2027
{"application_id":"66226","ingredient":"TREPROSTINIL","trade_name":"TYVASO","family_id":"bad307ec11e54475ad0b","publication_number":"US10376525B2","cleaned_patent_number":"10376525","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-14","publication_date":"2019-08-13","legal_status":"Granted"} US10376525B2 13 Aug, 2019 Granted 14 May, 2027
{"application_id":"66214","ingredient":"TREPROSTINIL","trade_name":"TYVASO DPI","family_id":"bad307ec11e54475ad0b","publication_number":"US10716793B2","cleaned_patent_number":"10716793","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-14","publication_date":"2020-07-21","legal_status":"Granted"} US10716793B2 21 Jul, 2020 Granted 14 May, 2027
{"application_id":"66224","ingredient":"TREPROSTINIL","trade_name":"TYVASO","family_id":"bad307ec11e54475ad0b","publication_number":"US9339507B2","cleaned_patent_number":"9339507","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-10","publication_date":"2016-05-17","legal_status":"Granted"} US9339507B2 Formulation 17 May, 2016 Granted 10 Mar, 2028
{"application_id":"66225","ingredient":"TREPROSTINIL","trade_name":"TYVASO","family_id":"bad307ec11e54475ad0b","publication_number":"US9358240B2","cleaned_patent_number":"9358240","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-05-05","publication_date":"2016-06-07","legal_status":"Granted"} US9358240B2 07 Jun, 2016 Granted 05 May, 2028
{"application_id":"62902","ingredient":"TREPROSTINIL","trade_name":"REMODULIN","family_id":"03558f09a5a6481b90c0","publication_number":"US8658694B2","cleaned_patent_number":"8658694","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-05","publication_date":"2014-02-25","legal_status":"Granted"} US8658694B2 25 Feb, 2014 Granted 05 Sep, 2028
{"application_id":"62888","ingredient":"TREPROSTINIL","trade_name":"REMODULIN","family_id":"03558f09a5a6481b90c0","publication_number":"US8653137B2","cleaned_patent_number":"8653137","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-05","publication_date":"2014-02-18","legal_status":"Patented case"} US8653137B2 18 Feb, 2014 Patented case 05 Sep, 2028
{"application_id":"62962","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US9604901B2","cleaned_patent_number":"9604901","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2017-03-28","legal_status":"Patented case"} US9604901B2 Molecular 28 Mar, 2017 Patented case 15 Dec, 2028
{"application_id":"62982","ingredient":"TREPROSTINIL","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US11723887B2","cleaned_patent_number":"11723887","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2023-08-15","legal_status":"Granted"} US11723887B2 Molecular 15 Aug, 2023 Granted 15 Dec, 2028
{"application_id":"62975","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US8497393B2","cleaned_patent_number":"8497393","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2013-07-30","legal_status":"Granted"} US8497393B2 Molecular 30 Jul, 2013 Granted 15 Dec, 2028
{"application_id":"62978","ingredient":"TREPROSTINIL","trade_name":"ORENITRAM","family_id":"35c9cff7da204e0993e9","publication_number":"US9593066B2","cleaned_patent_number":"9593066","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-15","publication_date":"2017-03-14","legal_status":"Granted"} US9593066B2 Molecular 14 Mar, 2017 Granted 15 Dec, 2028
{"application_id":"62901","ingredient":"TREPROSTINIL","trade_name":"REMODULIN","family_id":"03558f09a5a6481b90c0","publication_number":"US7999007B2","cleaned_patent_number":"7999007","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-29","publication_date":"2011-08-16","legal_status":"Granted"} US7999007B2 Formulation 16 Aug, 2011 Granted 29 Mar, 2029
{"application_id":"62929","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"527227552b9a488c861d","publication_number":"US8410169B2","cleaned_patent_number":"8410169","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-13","publication_date":"2013-04-02","legal_status":"Granted"} US8410169B2 Formulation 02 Apr, 2013 Granted 13 Feb, 2030
{"application_id":"66183","ingredient":"TREPROSTINIL","trade_name":"TYVASO DPI","family_id":"7d1772cbdcd041f094b7","publication_number":"US10772883B2","cleaned_patent_number":"10772883","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-11","publication_date":"2020-09-15","legal_status":"Granted"} US10772883B2 Formulation 15 Sep, 2020 Granted 11 Jun, 2030
{"application_id":"86995","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"c1caa6ea226c4dcfb577","publication_number":"US8349892B2","cleaned_patent_number":"8349892","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-22","publication_date":"2013-01-08","legal_status":"Granted"} US8349892B2 Formulation 08 Jan, 2013 Granted 22 Jan, 2031
{"application_id":"86989","ingredient":"TREPROSTINIL DIOLAMINE","trade_name":"ORENITRAM","family_id":"e0a6905a106b4b169ee1","publication_number":"US8747897B2","cleaned_patent_number":"8747897","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-11","publication_date":"2014-06-10","legal_status":"Granted"} US8747897B2 Formulation 10 Jun, 2014 Granted 11 Aug, 2031
{"application_id":"66152","ingredient":"TREPROSTINIL","trade_name":"TYVASO DPI","family_id":"42639e324671491ab5f0","publication_number":"US10421729B2","cleaned_patent_number":"10421729","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-01","publication_date":"2019-09-24","legal_status":"Granted"} US10421729B2 Formulation 24 Sep, 2019 Granted 01 Apr, 2035
{"application_id":"242112","ingredient":"TREPROSTINIL SODIUM","trade_name":"YUTREPIA","family_id":"","publication_number":"US11744836B2","cleaned_patent_number":"11744836","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-05","publication_date":"2023-09-05","legal_status":"Granted"} US11744836B2 Formulation 05 Sep, 2023 Granted 05 May, 2037
{"application_id":"242109","ingredient":"TREPROSTINIL SODIUM","trade_name":"YUTREPIA","family_id":"","publication_number":"US11712442B2","cleaned_patent_number":"11712442","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-05","publication_date":"2023-08-01","legal_status":"Granted"} US11712442B2 01 Aug, 2023 Granted 05 May, 2037
{"application_id":"242113","ingredient":"TREPROSTINIL SODIUM","trade_name":"YUTREPIA","family_id":"","publication_number":"US11744835B2","cleaned_patent_number":"11744835","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-05","publication_date":"2023-09-05","legal_status":"Granted"} US11744835B2 Formulation 05 Sep, 2023 Granted 05 May, 2037
{"application_id":"242110","ingredient":"TREPROSTINIL SODIUM","trade_name":"YUTREPIA","family_id":"","publication_number":"US10898494B2","cleaned_patent_number":"10898494","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-05","publication_date":"2021-01-26","legal_status":"Granted"} US10898494B2 26 Jan, 2021 Granted 05 May, 2037
{"application_id":"242111","ingredient":"TREPROSTINIL SODIUM","trade_name":"YUTREPIA","family_id":"","publication_number":"US11660304B2","cleaned_patent_number":"11660304","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-05-05","publication_date":"2023-05-30","legal_status":"Granted"} US11660304B2 30 May, 2023 Granted 05 May, 2037
{"application_id":"117836","ingredient":"TREPROSTINIL","trade_name":"TYVASO","family_id":"6bcfc6cb395a421fae6f","publication_number":"US11826327B2","cleaned_patent_number":"11826327","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-02-03","publication_date":"2023-11-28","legal_status":"Granted"} US11826327B2 28 Nov, 2023 Granted 03 Feb, 2042

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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