The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for its generic drug Memantine Hydrochloride tablets in 5 mg and 10 mg strengths. Orchid’s product is determined to be the generic equivalent of Forest Laboratories’ Namenda 5 mg and 10 mg.

Memantine is prescribed for the treatment of Alzheimer's disease. Orchid filed its ANDA for this product under the Paragraph IV, First-to-file (FTF) certification. The product is under patent litigation between Orchid and Forest.

According to IMS, the market for Memantine tablets is around US$ 1.1 billion.