Granules India gets USFDA tentative nod  for generic ADHD treatment tablets

Key Highlights

• “The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market,” the company said.
• The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and has an estimated market size of USD 41 million, it added.
• “Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics.
• It also reinforces our commitment to strengthening our presence in the central nervous system (CNS) therapeutic space while enhancing value creation in the US generics market,” Granules India Chairman & Managing Director Krishna Prasad Chigurupati said.
• As per the USFDA, 180-day marketing exclusivity is granted to the first approved applicant for a generic version after challenging a listed patent.