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 is backward integrated with in-house API source for this product. 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.
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 commercial launch date and as per criteria set out by US FDA.
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.
The announcement was made after market hours yesterday, 22 April 2021. Shares of Gland Pharma rose 0.58% to settle at Rs 2,657.95 yesterday.
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Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions and also enjoys the distinction of having pioneered Heparin technology in India.
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