NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as KYOWA KIRIN. It is marketed under 1 brand name, including NOURIANZ. Available in 2 different strengths, such as 20MG, 40MG, 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":"97118","ingredient":"ISTRADEFYLLINE","trade_name":"NOURIANZ","family_id":"ec60efc14a2144c5856c","publication_number":"US8318201B2","cleaned_patent_number":"8318201","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-05","publication_date":"2012-11-27","legal_status":"Granted"} | US8318201B2 Formulation | 27 Nov, 2012 | Granted | 05 Sep, 2027 | |
| {"application_id":"97066","ingredient":"ISTRADEFYLLINE","trade_name":"NOURIANZ","family_id":"d2cca9ae73f94345aca5","publication_number":"US7727993B2","cleaned_patent_number":"7727993","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-28","publication_date":"2010-06-01","legal_status":"Expired"} | US7727993B2 Formulation | 01 Jun, 2010 | Expired | 28 Jan, 2028 |
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.