Glenmark obtains FDA green light for generic Qudexy

Patients with certain types of seizures and those seeking to prevent migraine headaches will soon have a new generic treatment.

The Food and Drug Administration has cleared Glenmark’s topiramate extended-release capsules, in dosage strengths of 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.

The drug is used to prevent migraine headaches in adults and adolescents 12 years and older; to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older; and with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

Glenmark’s product is the generic of Upsher-Smith’s Qudexy XR capsules.

Qudexy XR capsules had a market value of about $120.8 million for the 12 month period ended December 2020, according to IQVIA.