NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 16 pharmaceutical companies such as APOTEX INC, PHARMOBEDIENT, UNICHEM LABS LTD and others. It is marketed under 2 brand names, including TIZANIDINE HYDROCHLORIDE, ONTRALFY. Available in 4 different strengths, such as EQ 2MG BASE, EQ 6MG BASE, EQ 4MG BASE and others, and administered through 3 routes including CAPSULE;ORAL, TABLET;ORAL, SOLUTION;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":"139393","ingredient":"TIZANIDINE HYDROCHLORIDE","trade_name":"ONTRALFY","family_id":"","publication_number":"US12042484B2","cleaned_patent_number":"12042484","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-05-07","publication_date":"2024-07-23","legal_status":"Granted"} | US12042484B2 Formulation | 23 Jul, 2024 | Granted | 07 May, 2042 | |
| {"application_id":"164439","ingredient":"TIZANIDINE HYDROCHLORIDE","trade_name":"ONTRALFY","family_id":"","publication_number":"US12263158B2","cleaned_patent_number":"12263158","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2042-05-07","publication_date":"2025-04-01","legal_status":"Granted"} | US12263158B2 Formulation | 01 Apr, 2025 | Granted | 07 May, 2042 |
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.