Gland Pharma gets US FDA nod for generic Foscarnet Sodium Injection, Single-Dose Bag for Infusion

Gland Pharma received approval from the United States Food and Drug Administration (US FDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion. Generic Foscarnet Sodium Injection is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Foscavir Injection, 24 mg/mL, of Clinigen Healthcare. With this approval, Gland Pharma secured the first generic offering status in Single-Dose Bag for Infusion.

Gland Pharma was granted a Competitive Generic Therapy (CGT) designation for Foscarnet Sodium Injection as it is the “first approved applicant” for such competitive generic therapy, as per US FDA norms and therefore, is eligible for 180 days of CGT exclusivity. This exclusivity will begin only after the commercial launch date and as per criteria set out by US FDA.

Gland Pharma is backward integrated with in-house API source for this product.

Foscarnet Sodium Injection 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.

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, according to IQVIA.

Gland Pharma intends to supply this product globally and recently launched the product in the Canadian market. Global markets size is estimated to be $50 million.