Lupin receives USFDA approval to launch generic partial-onset treatment drug in US

Lupin on Wednesday, May 7, launched the generic version of its Eslicarbazepine Acetate tablets for the US markets.

The drug, used for partial-onset seizure treatment, was launched in 200 mg, 600 mg and 800 mg strengths. This follows approval of its abbreviated new drug application (ANDA) from the US Food and Drug Administration (USFDA), the pharma major stated in a regulatory filing.

Eslicarbazepine Acetate tablets, 200 mg, 400 mg, 600 mg and 800 mg are bioequivalent to Aptiom tablets in the same strengths of Sumitomo Pharma America, Inc.

Citing IQVIA MAT March 2025 data, Lupin said Eslicarbazepine Acetate tablets, Aptiom, had estimated annual sales of $395 million in the US.

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older, the company said.

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.

Lupin stock performance

Shares of Lupin closed 1.09% higher at ₹2,071.40 apiece on the National Stock Exchange (NSE) on Wednesday.

The stock gained 0.70% over the past three days but lost 1.15% since the beginning of May. The scrip has fallen 12.07% on a year-to-date basis.

The pharma share touched a 52-week high of ₹2,402.90 on January 2, 2025 and a low of ₹1,493.30 on June 4, 2024.

Lupin has a total market capitalisation of ₹94,656.61 crore, as of May 7, 2025, on the NSE.