Alembic Pharma gets US regulator nod for Asenapine sublingual tablets; stock rises 3 per cent

Pharma major, Alembic Pharmaceuticals Limited informed the exchanges on Friday that it has received approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Asenapine sublingual tablets, 5 mg & 10 mg.

Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults and have an estimated market size of US$ 217 million for the twelve-month ending September 2020, according to IMS Health.

The above-mentioned drug is therapeutically equivalent to the reference listed drug product (RLD), Saphris sublingual tablets, 5 mg & 10 mg of Allergan Sales, LLC (Allergan).

The company had previously received tentative approval for this ANDA and was one of the first ANDA applicants to complete an ANDA with a paragraph IV certification and hence, is eligible for 180 days of shared exclusivity.

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

On Friday, the stock of Alembic Pharmaceuticals closed at Rs 1,088.05 per share, up by 2.62 per cent or Rs 27.75 per share on BSE, against a 0.30 per cent gain in the benchmark index. The 52-week high was recorded at Rs 1,128.00 and the 52-week low was Rs 436.10 on BSE.