Ivax Corporation said that the Federal District Court in New Jersey denied the motion of plaintiff Pfizer Inc for a temporary restraining order and preliminary injunction which sought to block the sale by Ivax of gabapentin tablets in 100 mg, 300 mg and 400 mg strengths. As a result, Ivax, through its US generics subsidiary, Ivax Pharmaceuticals Inc will continue its launch of gabapentin tablets in 100 mg, 300 mg and 400 mg strengths, which commenced August 18, 2004, release from Ivax said.
Ivax received final approval of its Abbreviated New Drug Application for these tablets from the FDA in April 2004. As the first company to file an ANDA with a Paragraph IV patent certification, Ivax has been awarded 180-days marketing exclusivity for 100 mg, 300 mg and 400 mg tablets. Gabapentin is the generic name of Neurontin, approved to treat seizures and postherpetic neuralgia (PHN), and is marketed by Warner-Lambert, a unit of Pfizer Inc. Neurontin had US sales of approximately $2.4 billion in 2003.
Neurontin is sold by Warner-Lambert in 5 dosage strengths: 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. In addition to Ivax's first-to-file FDA approval for 100, 300 and 400 mg gabapentin tablets, Ivax has received a tentative approval from the United States Food and Drug Administration (FDA) for its ANDA for the 100 mg, 300 mg, and 400 mg capsules, and on the 600 mg and 800 mg tablets marketed by Warner-Lambert. Litigation with Pfizer concerning the Neurontin patent is pending and a trial has not yet been scheduled, the release added.