Gland Pharm was granted a competitive generic therapy (CGT) designation for Foscarnet Sodium injection and therefore is eligible for 180 days of CGT exclusivity, the filing said.
This exclusivity will begin only after the commercial launch date.
According to IQVIA, the Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) and its generic equivalents had US sales of approximately USD 28 million for twelve months ending in January 2021, the filing said.
The product is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
It is also used for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients.
Shares of Gland Pharma Ltd closed at Rs 2,657.95 per scrip on BSE, up 0.58 percent from its previous close.