Alembic Pharma Gets USFDA Approval For Generic Paliperidone Tablets

Alembic Pharmaceuticals Ltd has received final approval from the US FDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia.

The approved strengths are 1.5 mg, 3 mg, 6 mg, and 9 mg, and the product is therapeutically equivalent to Janssen's Invega.

Paliperidone is also indicated for schizoaffective disorder. According to IQVIA data, the market size for these tablets is estimated at $48 million for the 12 months ending June 2024.

Alembic now has a total of 215 ANDA approvals from the USFDA, including 187 final and 28 tentative approvals.

(With Inputs From PTI.)d