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.