Alembic Pharma gains after USFDA approval for asenapine sublingual tablets

Alembic Pharmaceuticals rose 1.32% to Rs 1,074.30 after the company announced that it received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets.

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 $217 million for twelve months ending September 2020 according to IQVIA.

Alembic Pharmaceuticals reported a 30% jump in consolidated net profit to Rs 325.41 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.

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