Alembic Pharma Gets USFDA Nod for Generic Paliperidone Tablets, Targets $48M Market

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its generic Paliperidone extended-release tablets. These tablets, used for treating schizophrenia, have notable market potential. Alembic now boasts a total of 215 ANDA approvals, including final and tentative ones.

Alembic Pharmaceuticals Ltd announced on Friday that it has secured final approval from the US Food & Drug Administration (USFDA) for its generic version of Paliperidone extended-release tablets. These tablets are prescribed for the treatment of schizophrenia.

The approval includes various strengths—1.5 mg, 3 mg, 6 mg, and 9 mg—according to Alembic Pharmaceuticals' regulatory filing. The authorized ANDA is deemed therapeutically equivalent to Invega extended-release tablets, produced by Janssen Pharmaceuticals, Inc.

Paliperidone extended-release tablets are known as atypical antipsychotic agents, indicated not only for schizophrenia but also for schizoaffective disorder, either as monotherapy or alongside mood stabilizers and antidepressants. According to IQVIA data, these tablets have an approximate market size of USD 48 million for the 12 months ending June 2024. Alembic Pharma has now accumulated a total of 215 ANDA approvals from USFDA, including 187 final approvals and 28 tentative ones.

(With inputs from agencies.)