NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as NOVARTIS, RICONPHARMA LLC. It is marketed under 2 brand names, including MAYZENT, SIPONIMOD. Available in 3 different strengths, such as EQ 0.25MG BASE, EQ 2MG BASE, EQ 1MG BASE, and administered through 1 route including TABLET;ORAL.
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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":"96233","ingredient":"SIPONIMOD","trade_name":"MAYZENT","family_id":"908a56ebdce44da6a322","publication_number":"US7939519B2","cleaned_patent_number":"7939519","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-27","publication_date":"2011-05-10","legal_status":"Granted"} | US7939519B2 Molecular Formulation | 10 May, 2011 | Granted | 27 Aug, 2028 | |
| {"application_id":"96190","ingredient":"SIPONIMOD","trade_name":"MAYZENT","family_id":"dd8e93495adb43609ca1","publication_number":"US8492441B2","cleaned_patent_number":"8492441","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-30","publication_date":"2013-07-23","legal_status":"Granted"} | US8492441B2 | 23 Jul, 2013 | Granted | 30 Nov, 2030 | |
| {"application_id":"130739","ingredient":"SIPONIMOD","trade_name":"MAYZENT","family_id":"","publication_number":"US12071402B2","cleaned_patent_number":"12071402","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-05","publication_date":"2024-08-27","legal_status":"Granted"} | US12071402B2 Formulation | 27 Aug, 2024 | Granted | 05 Jan, 2032 | |
| {"application_id":"123317","ingredient":"SIPONIMOD","trade_name":"MAYZENT","family_id":"","publication_number":"US11944602B2","cleaned_patent_number":"11944602","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-04-23","publication_date":"2024-04-02","legal_status":"Granted"} | US11944602B2 | 02 Apr, 2024 | Granted | 23 Apr, 2036 |
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.