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Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse

• Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate). • The generic Vyvanse will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules, indicated for ADHD treatment. • IQVIA reported annual sales of $4.3 billion for the brand and generic market of Lisdexamfetamine Dimesylate for the twelve months ending September 2024.

Elite Pharmaceuticals, Inc. (OTCQB: ELTP) has secured FDA approval for its generic version of Vyvanse (Lisdexamfetamine Dimesylate) capsules, marking a significant milestone for the specialty pharmaceutical company. The approval covers strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg, all indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This approval allows Elite to enter a market with substantial sales, potentially offering a more affordable alternative to patients.

Market Opportunity

According to IQVIA data, the combined annual sales for both the brand-name Vyvanse and its generic equivalents reached $4.3 billion for the twelve-month period ending in September 2024. This demonstrates the significant demand for Lisdexamfetamine Dimesylate products, highlighting the commercial potential of Elite's newly approved generic version.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is focused on developing, manufacturing, and distributing niche generic products. The company’s portfolio includes immediate-release and controlled-release solid oral dose products, marketed under the Elite Laboratories label and through licensing agreements with third-party organizations. Elite operates a cGMP and DEA-registered facility in Northvale, NJ, dedicated to research, development, and manufacturing.
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Reference News

[1]
Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse - Wiarton Echo
wiartonecho.com · Nov 18, 2024

Elite Pharmaceuticals receives FDA approval for a generic version of Vyvanse® (Lisdexamfetamine Dimesylate) capsules, in...

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