NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 20 pharmaceutical companies such as TAKEDA PHARMS USA, ALKEM LABS LTD, AMNEAL and others. It is marketed under 3 brand names, including VYVANSE, LISDEXAMFETAMINE DIMESYLATE, ARYNTA. Available in 8 different strengths, such as 10MG, 50MG, 40MG and others, and administered through 3 routes including CAPSULE;ORAL, TABLET, CHEWABLE;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 | |
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| {"application_id":"242132","ingredient":"LISDEXAMFETAMINE DIMESYLATE","trade_name":"ARYNTA","family_id":"","publication_number":"US11576878B2","cleaned_patent_number":"11576878","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-30","publication_date":"2023-02-14","legal_status":"Granted"} | US11576878B2 Formulation | 14 Feb, 2023 | Granted | 30 Aug, 2040 |
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.