The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for 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.