Aminolevulinic Acid Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as BIOFRONTERA, NXDC. It is marketed under 2 brand names, including AMELUZ, GLEOLAN. Available in 2 different strengths, such as 10%, 1.5GM/VIAL, and administered through 2 routes including GEL;TOPICAL, FOR SOLUTION;ORAL.

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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":"110498","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"AMELUZ","family_id":"fbf8ee1687fd47fdb617","publication_number":"US11540981B2","cleaned_patent_number":"11540981","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-07","publication_date":"2023-01-03","legal_status":"Granted"} US11540981B2 Formulation 03 Jan, 2023 Granted 07 Feb, 2028
{"application_id":"242144","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"","publication_number":"US11179574B2","cleaned_patent_number":"11179574","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-13","publication_date":"2021-11-23","legal_status":"Granted"} US11179574B2 23 Nov, 2021 Granted 13 Oct, 2036
{"application_id":"242141","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"","publication_number":"US12290700B2","cleaned_patent_number":"12290700","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-13","publication_date":"2025-05-06","legal_status":"Granted"} US12290700B2 06 May, 2025 Granted 13 Oct, 2036
{"application_id":"242142","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"","publication_number":"US11697028B2","cleaned_patent_number":"11697028","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-13","publication_date":"2023-07-11","legal_status":"Granted"} US11697028B2 11 Jul, 2023 Granted 13 Oct, 2036
{"application_id":"242143","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"","publication_number":"US11446512B2","cleaned_patent_number":"11446512","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-01-17","publication_date":"2022-09-20","legal_status":"Granted"} US11446512B2 20 Sep, 2022 Granted 17 Jan, 2037
{"application_id":"116038","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US2023321243A1","cleaned_patent_number":"12296011","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2025-05-13","legal_status":"Granted"} US12296011B2 13 May, 2025 Granted 12 Jan, 2038
{"application_id":"80573","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US11077192B2","cleaned_patent_number":"11077192","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2021-08-03","legal_status":"Granted"} US11077192B2 03 Aug, 2021 Granted 12 Jan, 2038
{"application_id":"80582","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US11135293B2","cleaned_patent_number":"11135293","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2021-10-05","legal_status":"Granted"} US11135293B2 05 Oct, 2021 Granted 12 Jan, 2038
{"application_id":"80583","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US11571478B2","cleaned_patent_number":"11571478","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2023-02-07","legal_status":"Granted"} US11571478B2 07 Feb, 2023 Granted 12 Jan, 2038
{"application_id":"116037","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US11690914B2","cleaned_patent_number":"11690914","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2023-07-04","legal_status":"Granted"} US11690914B2 04 Jul, 2023 Granted 12 Jan, 2038
{"application_id":"80581","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"LEVULAN","family_id":"69c8052615e44375bcd5","publication_number":"US10357567B1","cleaned_patent_number":"10357567","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-01-12","publication_date":"2019-07-23","legal_status":"Patented case"} US10357567B2 23 Jul, 2019 Patented case 12 Jan, 2038
{"application_id":"59299","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"AMELUZ","family_id":"44403af0f17d416fae17","publication_number":"US11235169B1","cleaned_patent_number":"11235169","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-10-15","publication_date":"2022-02-01","legal_status":"Granted"} US11235169B2 01 Feb, 2022 Granted 15 Oct, 2040
{"application_id":"242105","ingredient":"AMINOLEVULINIC ACID HYDROCHLORIDE","trade_name":"AMELUZ","family_id":"","publication_number":"US12280146B2","cleaned_patent_number":"12280146","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-12-08","publication_date":"2025-04-22","legal_status":"Granted"} US12280146B2 Formulation 22 Apr, 2025 Granted 08 Dec, 2043

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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