Lupin receives FDA OK for generic Aptiom
Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients aged 4 years old and older.
Lupin has received the Food and Drug Administration’s green light for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg and 800 mg, which is a generic of Sumitomo Pharma’s Aptiom.
Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.
Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients aged 4 years old and older.
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Eslicarbazepine Acetate Tablets (RLD Aptiom) had a market value of roughly $354 million, per IQVIA January 2024 data.