Lupin gets approval for generic Ingrezza, launches generic Oracea

Lupin has received approval from the FDA for Valbenazine Capsules, 40 mg and 80 mg, which is a generic of Neurocrine Biosciences’ Ingrezza.

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. 

The product will be manufactured at Lupin’s Nagpur facility in India.

Ingrezza is used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia); involuntary movements (chorea) of Huntington’s disease. 

[Read more: Lupin receives FDA OK for generic Banzel]

Valbenazine Capsules, 40 mg and 80 mg (RLD Ingrezza) had a market value of approximately $1.6 billion, per IQVIA February 2024 data.

Lupin also announced it is introducing the first generic version of Oracea (Doxycycline Capsules, 40 mg)

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Doxycycline Capsules had a market value of roughly $128 million, per IQVIA February 2024 data.

[Read more:  Lupin receives FDA nod for 3 generics]