Apotex today announced that it has launched paroxetine hydrochloride tablets, 10mg, 20mg, 30mg and 40mg. The U.S. Food and Drug Administration has determined that Apotex' paroxetine tablets are therapeutically equivalent to GlaxoSmithKline's (GSK) Paxil.

Apotex was the first drug manufacturer to challenge the validity of patents covering Paxil and the first to gain FDA approval and bring a low-cost Paxil alternative to consumers.

"We consider it outrageous that GSK has kept an affordable alternative from consumers for years by asserting patents that they knew, or ought to have known, were either invalid or that our product did not infringe," said Apotex CEO Dr. Barry Sherman.

"Not only has Apotex experienced serious financial harm by this delay, but consumers have paid the price throughout this process. We are elated that finally we can bring this product to market," stated Tammy McIntire, president of Apotex' U.S. division.

In addition to making the finished product at its FDA-inspected, state-of-the-art manufacturing facility, Apotex also produces the active bulk ingredient through its Brantford Chemicals subsidiary.

"We are confident that we have made the right investment in this molecule and that our production capacity and inventory are sophisticated enough to handle the entire requirements of not only the U.S. market, but Canada and Europe as well," Sherman noted.

Paroxetine hydrochloride is the active ingredient in Paxil. U.S. sales of the brand drug were approximately $2.34 billion in 2002.

Paxil is a registered trademark of GlaxoSmithKline.

Apotex is the largest Canadian-owned manufacturer of prescription drugs in Canada. Apotex manufactured generic pharmaceuticals are sold in 115 countries around the world. Its extensive product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics, and inhalation solutions.