Lupin gains tentative FDA approval for Dolutegravir Tablets generic

Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Dolutegravir Tablets for Oral Suspension, 5 mg.

This approval will allow Lupin to market a generic equivalent of ViiV Healthcare’s Tivicay PD Tablets for Oral Suspension, 5 mg. The tablets will be produced at Lupin’s facility located in Nagpur, India.

Dolutegravir Tablets for Oral Suspension, the Reference Listed Drug (RLD) for Tivicay PD, had an estimated annual sales figure of $1 million in the US market, according to IQVIA MAT data up to March 2023. This tentative approval from the FDA signifies a potential expansion for Lupin in the generic pharmaceutical market in the US.

Tivicay PD Tablets, also known as Dolutegravir Tablets, are an antiretroviral medication used in the treatment of HIV (Human Immunodeficiency Virus) infections. They belong to a class of drugs known as integrase inhibitors. These drugs work by blocking the HIV integrase enzyme, a protein the virus requires to make more copies of itself in the body.

By inhibiting this enzyme, Dolutegravir can help to reduce the viral load, maintain the immune system, and slow the progression of HIV.

Tivicay PD (Pediatric Dispersible) tablets are specifically designed for oral suspension and are typically used in pediatric patients for the treatment of HIV-1 infection.