Glenmark Pharmaceuticals Inc., USA has announced plans to launch a generic version of Adderall tablets in May 2025. The product, officially named Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), will be available in five dosage strengths: 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg.
The company confirmed that their generic formulation is both bioequivalent and therapeutically equivalent to the reference listed drug, Adderall® Tablets, manufactured by Teva Women's Health, Inc. This equivalence ensures patients can expect similar efficacy and safety profiles when switching from the brand-name medication.
Market Impact and Financial Significance
According to IQVIA™ sales data for the 12-month period ending February 2025, the Adderall® Tablets market across all five dosage strengths generated approximately $421.7 million in annual sales. Glenmark's entry into this substantial market represents a significant opportunity for the company while potentially increasing accessibility for patients.
Marc Kikuchi, President & Business Head, North America at Glenmark, highlighted the importance of this launch: "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is a highly prescribed medication in the United States. Glenmark is very pleased to be able to help alleviate the shortage this country has been facing with this upcoming launch."
Addressing the Ongoing Shortage
The timing of Glenmark's launch is particularly relevant given the persistent shortages of Adderall that have affected patients across the United States. These shortages have created significant challenges for individuals with attention-deficit/hyperactivity disorder (ADHD) and narcolepsy, the primary conditions for which these medications are prescribed.
The addition of another manufacturer to the market may help stabilize the supply chain and improve medication access for patients who depend on these treatments for daily functioning. Healthcare providers have struggled to manage patients' needs during the shortage, often requiring medication switches or dose adjustments that can disrupt treatment efficacy.
About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. is a research-driven global pharmaceutical company with operations in over 80 countries. The company maintains a diverse portfolio across Branded, Generics, and OTC segments, with therapeutic focuses including cardio-metabolic, respiratory, dermatology, and oncology conditions.
With 11 manufacturing facilities across four continents, Glenmark ranks among the top 100 biopharmaceutical companies by pharmaceutical sales according to Scrip 100's 2023 rankings. The Generics Bulletin also places Glenmark in the top 50 generics and biosimilar companies by sales in 2024.
The company has demonstrated commitment to sustainability, with its greenhouse gas emission reduction targets approved by the Science Based Target initiative in 2023, making it only the second pharmaceutical company in India to achieve this distinction.
Regulatory and Distribution Details
Glenmark's generic Adderall product is approved only for the indications listed in the company's approved label. While the specific indications were not detailed in the announcement, the reference product Adderall is primarily indicated for ADHD and narcolepsy.
Distribution is scheduled to begin in May 2025, with the product expected to be available through standard pharmaceutical distribution channels. Healthcare providers and patients should consult with their pharmacies regarding availability once the product launches.
