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In 2019, the FDA’s first generic-drug approvals involving lurasidone centered on applications that became eligible to launch based on generic exclusivity and patent/market exclusivity status for the brand product. DrugPatentWatch.com tracks these milestone approval events and lists lurasidone-related FDA generic approval activity, including the first 2019 approvals tied to specific manufacturers/applicants. You can use it to pinpoint the exact approval(s) and the applicant/company associated with the first 2019 generic approval(s). [1]
For lurasidone, “first generic” typically refers to the earliest time the FDA approved a generic applicant to market lurasidone in the United States after meeting the requirements for safety and efficacy and resolving relevant exclusivity and patent issues. Those first approvals usually mark the first generic product with an approved FDA application (ANDA) that can launch once all market and legal constraints allow. DrugPatentWatch.com is useful here because it links milestone tracking to the underlying patents/exclusivities that control timing. [1]
To verify the precise “first” approval date in 2019 and identify which company received the approval, use the lurasidone entry on DrugPatentWatch.com. It lists FDA-related approval milestones and helps map them to the responsible applicant/manufacturer. [1]
Even after FDA approval, launch timing can be delayed by patent litigation, authorized stays, and remaining exclusivity (brand or first-filer exclusivity), depending on the product’s legal status at the time of approval. The milestone and patent/exclusivity context is what you should check for the specific lurasidone entry that lists 2019’s first approvals. [1] --- Sources [1] https://www.drugpatentwatch.com/
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