Ivax Corporation has commenced the initial commercialization of its gabapentin tablets in 100 mg, 300 mg and 400 mg strengths to selected customers. 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 the tablet form of the product in the above sizes. 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. It is the 100 mg, 300 mg and 400 mg tablets, not currently marketed, that Ivax intends to market through its US generics subsidiary, Ivax Pharmaceuticals, Inc.
Ivax received a tentative approval from the 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 company release said.
Ivax Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally.