Mirdametinib Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as SPRINGWORKS. It is marketed under 1 brand name, including GOMEKLI. Available in 2 different strengths, such as 1MG, 2MG, and administered through 2 routes including CAPSULE;ORAL, TABLET, FOR SUSPENSION;ORAL.

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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":"164397","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"5e97f9805af945d4baa0","publication_number":"US11066358B1","cleaned_patent_number":"11066358","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2021-07-20","legal_status":"Granted"} US11066358B2 Molecular 20 Jul, 2021 Granted 17 Feb, 2041
{"application_id":"164396","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"2a63e1972e5c4ee19b47","publication_number":"US11084780B1","cleaned_patent_number":"11084780","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2021-08-10","legal_status":"Granted"} US11084780B2 Molecular 10 Aug, 2021 Granted 17 Feb, 2041
{"application_id":"164389","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"5e97f9805af945d4baa0","publication_number":"US11453641B2","cleaned_patent_number":"11453641","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2022-09-27","legal_status":"Granted"} US11453641B2 27 Sep, 2022 Granted 17 Feb, 2041
{"application_id":"164471","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11571402B2","cleaned_patent_number":"11571402","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2023-02-07","legal_status":"Granted"} US11571402B2 Formulation 07 Feb, 2023 Granted 17 Feb, 2041
{"application_id":"164388","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11806321B2","cleaned_patent_number":"11806321","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2023-11-07","legal_status":"Granted"} US11806321B2 07 Nov, 2023 Granted 17 Feb, 2041
{"application_id":"164386","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11819487B2","cleaned_patent_number":"11819487","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2023-11-21","legal_status":"Granted"} US11819487B2 21 Nov, 2023 Granted 17 Feb, 2041
{"application_id":"164384","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12011424B2","cleaned_patent_number":"12011424","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2024-06-18","legal_status":"Granted"} US12011424B2 18 Jun, 2024 Granted 17 Feb, 2041
{"application_id":"164394","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"5e97f9805af945d4baa0","publication_number":"US12037306B2","cleaned_patent_number":"12037306","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2024-07-16","legal_status":"Granted"} US12037306B2 16 Jul, 2024 Granted 17 Feb, 2041
{"application_id":"164470","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12090128B2","cleaned_patent_number":"12090128","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2024-09-17","legal_status":"Granted"} US12090128B2 Formulation 17 Sep, 2024 Granted 17 Feb, 2041
{"application_id":"164390","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12263146B2","cleaned_patent_number":"12263146","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2025-04-01","legal_status":"Granted"} US12263146B2 01 Apr, 2025 Granted 17 Feb, 2041
{"application_id":"164392","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"2a63e1972e5c4ee19b47","publication_number":"US12275688B2","cleaned_patent_number":"12275688","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2025-04-15","legal_status":"Granted"} US12275688B2 Formulation 15 Apr, 2025 Granted 17 Feb, 2041
{"application_id":"242094","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12295925B2","cleaned_patent_number":"12295925","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-02-17","publication_date":"2025-05-13","legal_status":"Granted"} US12295925B2 13 May, 2025 Granted 17 Feb, 2041
{"application_id":"164383","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11883375B2","cleaned_patent_number":"11883375","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2024-01-30","legal_status":"Granted"} US11883375B2 30 Jan, 2024 Granted 16 Mar, 2043
{"application_id":"242095","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12324791B2","cleaned_patent_number":"12324791","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2025-06-10","legal_status":"Granted"} US12324791B2 10 Jun, 2025 Granted 16 Mar, 2043
{"application_id":"164385","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11839595B2","cleaned_patent_number":"11839595","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2023-12-12","legal_status":"Granted"} US11839595B2 12 Dec, 2023 Granted 16 Mar, 2043
{"application_id":"164387","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US11806322B2","cleaned_patent_number":"11806322","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2023-11-07","legal_status":"Granted"} US11806322B2 07 Nov, 2023 Granted 16 Mar, 2043
{"application_id":"164393","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12220390B2","cleaned_patent_number":"12220390","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2025-02-11","legal_status":"Granted"} US12220390B2 11 Feb, 2025 Granted 16 Mar, 2043
{"application_id":"164391","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12257215B2","cleaned_patent_number":"12257215","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-03-16","publication_date":"2025-03-25","legal_status":"Granted"} US12257215B2 25 Mar, 2025 Granted 16 Mar, 2043
{"application_id":"164395","ingredient":"MIRDAMETINIB","trade_name":"GOMEKLI","family_id":"","publication_number":"US12029711B1","cleaned_patent_number":"12029711","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2044-03-15","publication_date":"2024-07-09","legal_status":"Granted"} US12029711B2 Formulation 09 Jul, 2024 Granted 15 Mar, 2044

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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