NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SUPERNUS PHARMS. It is marketed under 1 brand name, including QELBREE. Available in 3 different strengths, such as EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, and administered through 1 route including CAPSULE, EXTENDED RELEASE;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":"44702","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"292c57bd387642aaa65c","publication_number":"US11324753B2","cleaned_patent_number":"11324753","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-04","publication_date":"2022-05-10","legal_status":"Granted"} | US11324753B2 | 10 May, 2022 | Granted | 04 Sep, 2029 | |
| {"application_id":"44709","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"a65356b85be3448b8a7d","publication_number":"US11458143B2","cleaned_patent_number":"11458143","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-04","publication_date":"2022-10-04","legal_status":"Granted"} | US11458143B2 | 04 Oct, 2022 | Granted | 04 Sep, 2029 | |
| {"application_id":"138432","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"","publication_number":"US12121523B2","cleaned_patent_number":"12121523","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-04","publication_date":"2024-10-22","legal_status":"Granted"} | US12121523B2 | 22 Oct, 2024 | Granted | 04 Sep, 2029 | |
| {"application_id":"44696","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"e16ba2c3e1c641b5bfe4","publication_number":"US9358204B2","cleaned_patent_number":"9358204","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-07","publication_date":"2016-06-07","legal_status":"Granted"} | US9358204B2 Formulation | 07 Jun, 2016 | Granted | 07 Feb, 2033 | |
| {"application_id":"44685","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"e16ba2c3e1c641b5bfe4","publication_number":"US9603853B2","cleaned_patent_number":"9603853","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-07","publication_date":"2017-03-28","legal_status":"Granted"} | US9603853B2 | 28 Mar, 2017 | Granted | 07 Feb, 2033 | |
| {"application_id":"44697","ingredient":"VILOXAZINE HYDROCHLORIDE","trade_name":"QELBREE","family_id":"e16ba2c3e1c641b5bfe4","publication_number":"US9662338B2","cleaned_patent_number":"9662338","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-02","publication_date":"2017-05-30","legal_status":"Granted"} | US9662338B2 Formulation | 30 May, 2017 | Granted | 02 Apr, 2035 |
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.