NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 9 pharmaceutical companies such as GLENMARK PHARMS LTD, SUN PHARM INDS LTD, APOTEX CORP and others. It is marketed under 3 brand names, including RILUZOLE, TIGLUTIK KIT, EXSERVAN. Available in 2 different strengths, such as 50MG, 50MG/10ML, and administered through 3 routes including TABLET;ORAL, SUSPENSION;ORAL, FILM;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":"83230","ingredient":"RILUZOLE","trade_name":"TIGLUTIK KIT","family_id":"3f19826a114d4c96a1ad","publication_number":"US8765150B2","cleaned_patent_number":"8765150","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-12","publication_date":"2014-07-01","legal_status":"Granted"} | US8765150B2 Formulation | 01 Jul, 2014 | Granted | 12 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.