The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales.
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 $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.