Alembic Pharmaceuticals Limited (Alembic) today announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales, LLC (Allergan).

Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults. Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity. Asenapine Sublingual Tablets, 5 mg and 10 mg have an estimated market size of US$ 217 million for twelve months ending September 2020 according to IQVIA.

Alembic has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.