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What happened
Granules India Ltd said its arm Granules Pharmaceuticals, Inc. received tentative approval from the US Food and Drug Administration for generic amphetamine extended-release tablets indicated for treatment of attention deficit hyperactivity disorder. The tentative approval covers an abbreviated new drug application for 5 mg, 10 mg, 15 mg, and 20 mg strengths, and the tablets are the generic equivalent of DYANAVEL XR. Granules said the FDA determined the ANDA is eligible for 180-day exclusivity. Granules said the product has an estimated market size of USD 41 million.
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Key insights
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Company links exclusivity eligibility to strategy: Chairman and Managing Director Krishna Prasad Chigurupati said eligibility for 180-day exclusivity validates a long-term strategy to build a differentiated portfolio of complex generics and strengthens presence in the CNS therapeutic space.
Takeaways
Granules India reported USFDA tentative approval and 180-day exclusivity eligibility for its generic amphetamine extended-release ADHD tablets, alongside a prior tentative approval for a related ADHD product in December 2025.