Alpharma Expects Conclusion To Ivax Gabapentin Litigation
DOW JONES NEWSWIRES
February 2, 2005 6:06 p.m.
FORT LEE, N.J. -- Alpharma Inc. (ALO) said a decision in a lawsuit that could put an end to its right to sell Gabapentin, the generic version of Pfizer Inc.'s (PFE) popular epilepsy drug Neurontin, is approaching in February.
An adverse decision in the case would "materially impact the company's profitability in 2005," Alpharma warned.
In the suit, Ivax Corp. (IVX), a fellow generic drug maker which also makes a Neurontin copycat, filed an appeal seeking to reverse a District Court decision upholding Alpharma's right to exclusivity for gabapentin capsules and tablets.
A ruling in favor of Ivax could prematurely terminate Alpharma's 180 day exclusivity period for gabapentin capsules and tablets, which is currently expected to expire on April 6, 2005 and June 13, 2005, respectively.
The company has a partnership with Teva Pharmaceutical Industries Ltd. (TEVA) under which the companies share exclusivity on gabapentin tables and capsules.
Alpharma hasn't released figures for generic gabapentin sales, but a recent Wall Street Journal article citing NDCHealth of Atlanta noted that U.S. sales of the generic drug were $123 million in October and November.
Alpharma, which had net revenue of $298 million in its recent third quarter, said in its third-quarter announcement that it didn't expect to see a significant profit contribution in the fourth quarter from any U.S. generic new product launches other than gabapentin.
Other generics on the market include one from Greenstone Ltd., a Pfizer Inc. (PFE) subsidiary, and Ivax Corp.'s product.
Ivax's appeal was made public in December. At that time, a court also dismissed a similar claim against Alpharma on procedural grounds; Apotex Inc. (AOX.YY) had challenged the Food and Drug Administration's approval of generic market exclusivity for Alpharma's gabapentin capsules.
The current briefing schedule for the Ivax appeal ends in early February. Alpharma said it expects a decision "within a reasonable period" following that time. |
