budesonide

It is formulated by 26 pharmaceutical companies such as AUROBINDO PHARMA USA, IMPAX LABS INC, SALIX and others. It is marketed under 10 brand names, including BUDESONIDE, UCERIS, RHINOCORT ALLERGY and others. Available in 15 different strengths, such as 3MG, 0.25MG/2ML, 0.5MG/2ML and others, and administered through 7 routes including CAPSULE, DELAYED RELEASE;ORAL, SUSPENSION;INHALATION, TABLET, EXTENDED RELEASE;ORAL and others.

Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

Strategic Dashboard

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Sourcing & Feasibility

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groups Licensing: 26 potential partners

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factoryGeneric Manufacturer Snapshot

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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":"36199","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US11413296B2","cleaned_patent_number":"11413296","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2022-08-16","legal_status":"Granted"} US11413296B2 Formulation 16 Aug, 2022 Granted 09 Nov, 2026
{"application_id":"2748","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US11197822B2","cleaned_patent_number":"11197822","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2021-12-14","legal_status":"Granted"} US11197822B2 Formulation 14 Dec, 2021 Granted 09 Nov, 2026
{"application_id":"36195","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US9119863B2","cleaned_patent_number":"9119863","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2015-09-01","legal_status":"Granted"} US9119863B2 01 Sep, 2015 Granted 09 Nov, 2026
{"application_id":"36192","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US8497258B2","cleaned_patent_number":"8497258","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2013-07-30","legal_status":"Granted"} US8497258B2 30 Jul, 2013 Granted 09 Nov, 2026
{"application_id":"36193","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US8679545B2","cleaned_patent_number":"8679545","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2014-03-25","legal_status":"Granted"} US8679545B2 Formulation 25 Mar, 2014 Granted 09 Nov, 2026
{"application_id":"36194","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US8975243B2","cleaned_patent_number":"8975243","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-11-09","publication_date":"2015-03-10","legal_status":"Granted"} US8975243B2 10 Mar, 2015 Granted 09 Nov, 2026
{"application_id":"34366","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"6f864607551b4c4db8e8","publication_number":"US11357859B2","cleaned_patent_number":"11357859","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-12","publication_date":"2022-06-14","legal_status":"Granted"} US11357859B2 14 Jun, 2022 Granted 12 Nov, 2028
{"application_id":"34369","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"6f864607551b4c4db8e8","publication_number":"US10293052B2","cleaned_patent_number":"10293052","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-22","publication_date":"2019-05-21","legal_status":"Granted"} US10293052B2 Formulation 21 May, 2019 Granted 22 Nov, 2028
{"application_id":"44027","ingredient":"BUDESONIDE","trade_name":"TARPEYO","family_id":"072bf89e3d9740f9ac7d","publication_number":"US8491932B2","cleaned_patent_number":"8491932","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-07","publication_date":"2013-07-23","legal_status":"Granted"} US8491932B2 Formulation 23 Jul, 2013 Granted 07 May, 2029
{"application_id":"34368","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"6f864607551b4c4db8e8","publication_number":"US9050368B2","cleaned_patent_number":"9050368","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-01","publication_date":"2015-06-09","legal_status":"Patented case"} US9050368B2 Formulation 09 Jun, 2015 Patented case 01 Aug, 2029
{"application_id":"36191","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"a2df007ef9f141a3816b","publication_number":"US8324192B2","cleaned_patent_number":"8324192","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-03","publication_date":"2012-12-04","legal_status":"Granted"} US8324192B2 04 Dec, 2012 Granted 03 Aug, 2029
{"application_id":"43318","ingredient":"ALBUTEROL SULFATE; BUDESONIDE","trade_name":"AIRSUPRA","family_id":"b7a1dcda33db49ccb35b","publication_number":"US9415009B2","cleaned_patent_number":"9415009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2016-08-16","legal_status":"Granted"} US9415009B2 16 Aug, 2016 Granted 28 May, 2030
{"application_id":"43319","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US9463161B2","cleaned_patent_number":"9463161","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2016-10-11","legal_status":"Granted"} US9463161B2 Formulation 11 Oct, 2016 Granted 28 May, 2030
{"application_id":"43320","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US10716753B2","cleaned_patent_number":"10716753","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2020-07-21","legal_status":"Granted"} US10716753B2 Formulation 21 Jul, 2020 Granted 28 May, 2030
{"application_id":"43315","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8703806B2","cleaned_patent_number":"8703806","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2014-04-22","legal_status":"Granted"} US8703806B2 22 Apr, 2014 Granted 28 May, 2030
{"application_id":"43316","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8808713B2","cleaned_patent_number":"8808713","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2014-08-19","legal_status":"Granted"} US8808713B2 Formulation 19 Aug, 2014 Granted 28 May, 2030
{"application_id":"43174","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8324266B2","cleaned_patent_number":"8324266","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-28","publication_date":"2012-12-04","legal_status":"Granted"} US8324266B2 04 Dec, 2012 Granted 28 May, 2030
{"application_id":"43317","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"b7a1dcda33db49ccb35b","publication_number":"US8815258B2","cleaned_patent_number":"8815258","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-17","publication_date":"2014-08-26","legal_status":"Granted"} US8815258B2 26 Aug, 2014 Granted 17 Mar, 2031
{"application_id":"87496","ingredient":"BUDESONIDE","trade_name":"UCERIS","family_id":"26bc84c9f2a94a11b67e","publication_number":"US8895064B2","cleaned_patent_number":"8895064","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-07","publication_date":"2014-11-25","legal_status":"Granted"} US8895064B2 Formulation 25 Nov, 2014 Granted 07 Sep, 2031
{"application_id":"87497","ingredient":"BUDESONIDE","trade_name":"UCERIS","family_id":"26bc84c9f2a94a11b67e","publication_number":"US9132093B2","cleaned_patent_number":"9132093","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-07","publication_date":"2015-09-15","legal_status":"Granted"} US9132093B2 Formulation 15 Sep, 2015 Granted 07 Sep, 2031
{"application_id":"87470","ingredient":"BUDESONIDE","trade_name":"UCERIS","family_id":"26bc84c9f2a94a11b67e","publication_number":"US9192581B2","cleaned_patent_number":"9192581","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-07","publication_date":"2015-11-24","legal_status":"Granted"} US9192581B2 Formulation 24 Nov, 2015 Granted 07 Sep, 2031
{"application_id":"87510","ingredient":"BUDESONIDE","trade_name":"UCERIS","family_id":"26bc84c9f2a94a11b67e","publication_number":"US10660858B2","cleaned_patent_number":"10660858","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-07","publication_date":"2020-05-26","legal_status":"Granted"} US10660858B2 Formulation 26 May, 2020 Granted 07 Sep, 2031
{"application_id":"87509","ingredient":"BUDESONIDE","trade_name":"UCERIS","family_id":"26bc84c9f2a94a11b67e","publication_number":"US10307375B2","cleaned_patent_number":"10307375","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-07","publication_date":"2019-06-04","legal_status":"Granted"} US10307375B2 Formulation 04 Jun, 2019 Granted 07 Sep, 2031
{"application_id":"43904","ingredient":"BUDESONIDE","trade_name":"ORTIKOS","family_id":"59a1599d57e94519b6dc","publication_number":"US9707182B2","cleaned_patent_number":"9707182","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-09","publication_date":"2017-07-18","legal_status":"Granted"} US9707182B2 Formulation 18 Jul, 2017 Granted 09 Sep, 2036
{"application_id":"43900","ingredient":"BUDESONIDE","trade_name":"ORTIKOS","family_id":"59a1599d57e94519b6dc","publication_number":"US10172802B2","cleaned_patent_number":"10172802","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-09","publication_date":"2019-01-08","legal_status":"Granted"} US10172802B2 08 Jan, 2019 Granted 09 Sep, 2036
{"application_id":"43343","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"bff98297e8ad4b09adb0","publication_number":"US11331442B2","cleaned_patent_number":"11331442","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-05","publication_date":"2022-05-17","legal_status":"Granted"} US11331442B2 Formulation 17 May, 2022 Granted 05 Oct, 2038
{"application_id":"43354","ingredient":"BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE","trade_name":"BREZTRI AEROSPHERE","family_id":"bff98297e8ad4b09adb0","publication_number":"US11833292B2","cleaned_patent_number":"11833292","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-10-05","publication_date":"2023-12-05","legal_status":"Granted"} US11833292B2 Formulation 05 Dec, 2023 Granted 05 Oct, 2038
{"application_id":"122911","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"","publication_number":"US11564934B2","cleaned_patent_number":"11564934","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-10","publication_date":"2023-01-31","legal_status":"Granted"} US11564934B2 31 Jan, 2023 Granted 10 Jan, 2039
{"application_id":"122912","ingredient":"BUDESONIDE","trade_name":"EOHILIA","family_id":"","publication_number":"US11260064B2","cleaned_patent_number":"11260064","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-10","publication_date":"2022-03-01","legal_status":"Granted"} US11260064B2 Formulation 01 Mar, 2022 Granted 10 Jan, 2039
{"application_id":"179831","ingredient":"BUDESONIDE","trade_name":"TARPEYO","family_id":"84e96d1f777c4c7f8d15","publication_number":"US12311057B2","cleaned_patent_number":"12311057","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-23","publication_date":"2025-05-27","legal_status":"Granted"} US12311057B2 Formulation 27 May, 2025 Granted 23 Jan, 2043
{"application_id":"139363","ingredient":"BUDESONIDE","trade_name":"TARPEYO","family_id":"84e96d1f777c4c7f8d15","publication_number":"US12171882B2","cleaned_patent_number":"12171882","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-23","publication_date":"2024-12-24","legal_status":"Granted"} US12171882B2 24 Dec, 2024 Granted 23 Jan, 2043
{"application_id":"122882","ingredient":"BUDESONIDE","trade_name":"TARPEYO","family_id":"84e96d1f777c4c7f8d15","publication_number":"US11896719B2","cleaned_patent_number":"11896719","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-23","publication_date":"2024-02-13","legal_status":"Granted"} US11896719B2 13 Feb, 2024 Granted 23 Jan, 2043
{"application_id":"139364","ingredient":"BUDESONIDE","trade_name":"TARPEYO","family_id":"84e96d1f777c4c7f8d15","publication_number":"US12171883B2","cleaned_patent_number":"12171883","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-23","publication_date":"2024-12-24","legal_status":"Granted"} US12171883B2 Formulation 24 Dec, 2024 Granted 23 Jan, 2043

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

ACTAVIS LABS FL INC Total Dosages: 1
AMNEAL PHARMS Total Dosages: 1
APOTEX Total Dosages: 1 Manufacturing Locations: 10
AUROBINDO PHARMA USA Total Dosages: 1 Manufacturing Locations: 1
BARR LABS DIV TEVA Total Dosages: 1
CIPLA Total Dosages: 3 Manufacturing Locations: 7
DR REDDYS LABS SA Total Dosages: 1
EUGIA PHARMA Total Dosages: 1 Manufacturing Locations: 3
IMPAX LABS INC Total Dosages: 2
LUPIN Total Dosages: 1 Manufacturing Locations: 18
MYLAN Total Dosages: 3 Manufacturing Locations: 19
NATCO Total Dosages: 1 Manufacturing Locations: 8
NEPHRON Total Dosages: 2 Manufacturing Locations: 4
PADAGIS ISRAEL Total Dosages: 1 Manufacturing Locations: 1
RISING Total Dosages: 1 Manufacturing Locations: 20
SANDOZ Total Dosages: 3 Manufacturing Locations: 9
SCIECURE PHARMA INC Total Dosages: 1
SUN PHARM Total Dosages: 3 Manufacturing Locations: 21
TEVA PHARMS Total Dosages: 2
TEVA PHARMS USA Total Dosages: 1
ZYDUS PHARMS Total Dosages: 1

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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