Alpharma Gets First-to-File Status for Gabapentin Tablets

NJBIZ STAFF//August 9, 2005//

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Purepac Pharmaceutical, a subsidiary of Fort Lee generic pharmaceutical company Alpharma (NYSE: ALO), has received final approval from the Food and Drug Administration to market gabapentin tablets–a generic version of Pfizer”s successful Neurontin– in 600 mg and 800 mg dosages. Alpharma rolled out capsule versions of gabapentin in 100 mg, 300 mg and 400 mg dosages earlier this month. The company received first-to-file status and 180-day market exclusivity for all generic versions of Neurontin tablets.

Gabapentin will be marketed under the Purepac brand. Pfizer’s Neurontin is a treatment for partial seizures caused by epilepsy and post-herpetic neuralgias. Neurontin generated $700 million in sales for Pfizer in 2003. Alpharma has not announced when gabapentin will be on the market. Shares of Alpharma were up $0.32 to $16.91 in midday trading.