India Pharma Outlook Team | Thursday, 08 January 2026
Granules India announced today that U.S. based company, Granules Pharmaceuticals, Inc., has gotten probable designation of the U.S. Food and Drug Administration (FDA) on its generic amphetamine prolonged discharge pills that treat attention deficit hyperactivity disorder (ADHD).
The approval provides the company with a 180 days market exclusivity which is a huge benefit of generic drugs in the United States.
The FDA approval is under an abbreviated new drug application (ANDA) of the company to approve amphetamine extended-release tablets in 4 doses, including 5 mg, 10 mg, 15mg, and 20mg. These tablets are generic DYANAVEL XR, which Granules India announced to the authorities. Its product will target the emerging U.S. ADHD treatment market.
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Granules India reported that ANDA is qualified by the FDA to have 180-day exclusivity, implying that, the company can market the drug without generic competition within six months after its release into the market. The market size of the ADHD drug in the U.S. is approximated to be 41 million, and it has a good revenue opportunity.
The company has discovered that the Granules ANDA is eligible to receive 180-day exclusivity with the FDA that demonstrates our increasing capacity to create and commercialize complex and diverse generic items in the U.S. market.
Krishna Prasad Chigurupati, the Chairman and Managing Director, stated that the availability of a product where access is due to 180-days exclusivity is a significant support to our long-term goal of creating a special portfolio of complex generics. It also demonstrates that we are determined to expand in the central nervous system (CNS) market and value addition in the U.S. generics market.
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