Vamorolone Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as CATALYST PHARMS. It is marketed under 1 brand name, including AGAMREE. Available in 1 different strength, such as 40MG/ML, and administered through 1 route including SUSPENSION;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":"118081","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"0d72ebae6e48436abe8a","publication_number":"US10857161B2","cleaned_patent_number":"10857161","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-28","publication_date":"2020-12-08","legal_status":"Granted"} US10857161B2 Formulation 08 Dec, 2020 Granted 28 May, 2029
{"application_id":"118118","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"0d72ebae6e48436abe8a","publication_number":"US8334279B2","cleaned_patent_number":"8334279","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-28","publication_date":"2012-12-18","legal_status":"Granted"} US8334279B2 18 Dec, 2012 Granted 28 May, 2029
{"application_id":"118123","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"0d72ebae6e48436abe8a","publication_number":"US11833159B2","cleaned_patent_number":"11833159","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-28","publication_date":"2023-12-05","legal_status":"Granted"} US11833159B2 Formulation 05 Dec, 2023 Granted 28 May, 2029
{"application_id":"118073","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"f030283c027a412495c1","publication_number":"US11690853B2","cleaned_patent_number":"11690853","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-07","publication_date":"2023-07-04","legal_status":"Granted"} US11690853B2 04 Jul, 2023 Granted 07 Mar, 2033
{"application_id":"118077","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"3674e3568f1b4c4cab60","publication_number":"US11471471B2","cleaned_patent_number":"11471471","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-03-17","publication_date":"2022-10-18","legal_status":"Granted"} US11471471B2 18 Oct, 2022 Granted 17 Mar, 2040
{"application_id":"118079","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"3674e3568f1b4c4cab60","publication_number":"US2023027370A1","cleaned_patent_number":"12201639","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-03-17","publication_date":"2023-01-26","legal_status":"Pending"} US12201639B2 Molecular Formulation 26 Jan, 2023 Pending 17 Mar, 2040
{"application_id":"118078","ingredient":"VAMOROLONE","trade_name":"AGAMREE","family_id":"3674e3568f1b4c4cab60","publication_number":"US11382922B2","cleaned_patent_number":"11382922","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-16","publication_date":"2022-07-12","legal_status":"Granted"} US11382922B2 Molecular Formulation 12 Jul, 2022 Granted 16 Jul, 2040

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

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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.