Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Asenapine Sublingual tablets, indicated for treatment of bipolar disorder. The approved product is therapeutically equivalent to the reference listed drug product Saphris Sublingual tablets of Allergan Sales, LLC.
In a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets in the strengths of 5 mg and 10 mg.
Asenapine is an antipsychotic drug indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults. Alembic had previously received tentative approval for this ANDA. Alembic Pharma said it was one of the first applicants to submit a substantially complete ANDA and hence is eligible for 180 days of shared exclusivity. Quoting IQVIA data, Alembic Pharma said Asenapine Sublingual tablets, 5 mg and 10 mg, have an estimated market size of USD 217 million for 12 months ending September 2020.
Alembic Pharma has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.