Lupin Launches Generic Seizure Drug in US
Pharma giant Lupin Ltd has introduced a generic version of Eslicarbazepine Acetate tablets in the US, used for treating partial-onset seizures. The launch follows USFDA approval and comes with 180 days of shared generic exclusivity. The drug competes with Aptiom, which has US sales of $395 million.
- Country:
- India
Pharmaceutical leader Lupin Ltd announced on Wednesday the launch of its generic Eslicarbazepine Acetate tablets in the United States. This version targets partial-onset seizures, a prevalent condition, extending much-needed affordability.
Lupin's market entry follows the approval of its abbreviated new drug application (ANDA) from the USFDA, covering strengths of 200 mg, 400 mg, 600 mg, and 800 mg. Being among the first ANDA applicants, Lupin has earned 180 days of shared exclusivity for this generic variant.
This new entry mirrors the efficacy of Sumitomo Pharma America, Inc.'s Aptiom, which enjoys robust annual sales of $395 million in the US market per IQVIA MAT March 2025 data. Eslicarbazepine Acetate now awaits its impact on the competitive pharmaceutical landscape.
(With inputs from agencies.)
Google News