IVAX To Begin Marketing Gabapentin Capsules In March, Tablets In April, Prior To End Of Alpharma's Exclusivity Periods
DOW JONES NEWSWIRES
February 11, 2005 12:42 p.m.
MIAMI -- Ivax Corp. (IVX) settled litigation with the Food and Drug Administration and Alpharma Inc. (ALO), which allows Ivax to market a generic epileptic-seizure drug prior to the expiration of Alpharma's marketing exclusivity period.
Ivax had filed an appeal seeking to reverse a district court's decision upholding Alpharma's right to exclusivity for gabapentin capsules and tablets, generic versions of Pfizer Inc.'s (PFE) epileptic-seizure drug Neurontin.
Neurontin, marketed by Pfizer's Warner-Lambert unit, had U.S. sales of about $2.4 billion in 2003.
In a press release Friday, Ivax said it will have the right to begin marketing gabapentin capsules March 23, and gabapentin tables April 29, which is prior to the expiration of Alpharma's 180-day marketing and exclusivity period.
Alpharma's exclusivity period for its capsules was scheduled to expire in April, while its period for tablets was scheduled to expire on June 13.
Ivax said it is currently litigating whether its gabapentin products infringe a patent held by Pfizer. A trial in the U.S. District Court of New Jersey hasn't be been scheduled at this time.
IVAX's gabapentin capsules in 100mg, 300mg, and 400mg dosage strengths and tablets in 600mg and 800mg received tentative FDA approval.
Upon final approval, these products will be sold through Ivax Pharmaceuticals, which currently markets gabapentin tablets in 100mg, 300mg and 400mg dosage strengths, for which IVAX received 180-day marketing exclusivity.
Representatives from both Ivax and Alpharma weren't immediatly available for comment on the agreement and its expected material impact.
When Alpharma posted its third-quarter results, the company said that other than gabapentin, it doesn't expect a significant profit contribution in the fourth quarter from U.S. generic new product launches due to a challenging generic drug market
Earlier this month, Alpharma warned that an adverse decision, which would prematurely terminate the 180 day exclusivity period, could materially impact the company's profitability in 2005. Alpharma had 2003 net earnings of 32 cents a share on revenue of $1.3 billion.
However, Ivax said it expects a "good" fourth quarter and year because of strong U.S. generic product sales, including gabapentin. Ivax had 2003 net earnings of 61 cents a share on revenue of $1.42 billion. |
