NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as ASTRAZENECA. It is marketed under 1 brand name, including KOSELUGO. Available in 2 different strengths, such as EQ 10MG BASE, EQ 25MG BASE, and administered through 1 route including CAPSULE;ORAL.
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Licensing: 1 potential partnersUS Launch window: Loading launch window...
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"23052","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"1750bd859ab04d8792f4","publication_number":"US7425637B2","cleaned_patent_number":"7425637","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-13","publication_date":"2008-09-16","legal_status":"Expired"} | US7425637B2 Molecular | 16 Sep, 2008 | Expired | 13 Mar, 2026 | |
| {"application_id":"1591","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"1750bd859ab04d8792f4","publication_number":"US8178693B2","cleaned_patent_number":"8178693","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-03-13","publication_date":"2012-05-15","legal_status":"Expired"} | US8178693B2 Molecular Formulation | 15 May, 2012 | Expired | 13 Mar, 2026 | |
| {"application_id":"39628","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"2ca547d88ff245108699","publication_number":"US9562017B2","cleaned_patent_number":"9562017","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-12","publication_date":"2017-02-07","legal_status":"Granted"} | US9562017B2 Molecular | 07 Feb, 2017 | Granted | 12 Dec, 2026 | |
| {"application_id":"39658","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"2ca547d88ff245108699","publication_number":"US9156795B2","cleaned_patent_number":"9156795","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-12","publication_date":"2015-10-13","legal_status":"Granted"} | US9156795B2 Molecular Formulation | 13 Oct, 2015 | Granted | 12 Dec, 2026 | |
| {"application_id":"182180","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"0d6686a59b114525be54","publication_number":"US12318367B2","cleaned_patent_number":"12318367","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-26","publication_date":"2025-06-03","legal_status":"Granted"} | US12318367B2 Formulation | 03 Jun, 2025 | Granted | 26 Mar, 2029 | |
| {"application_id":"119520","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"0d6686a59b114525be54","publication_number":"US11813246B2","cleaned_patent_number":"11813246","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-26","publication_date":"2023-11-14","legal_status":"Granted"} | US11813246B2 Formulation | 14 Nov, 2023 | Granted | 26 Mar, 2029 | |
| {"application_id":"164399","ingredient":"SELUMETINIB SULFATE","trade_name":"KOSELUGO","family_id":"0d6686a59b114525be54","publication_number":"US12220403B2","cleaned_patent_number":"12220403","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-26","publication_date":"2025-02-11","legal_status":"Granted"} | US12220403B2 Formulation | 11 Feb, 2025 | Granted | 26 Mar, 2029 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.