India’s Lupin has become the first company to win approval in the USA for a generic version of Abbott Laboratories’ Omnicef, an antibiotic with sales of $495 million in 2005.

Launch of the product will depend on the outcome of patent litigation between the two companies, with Abbott claiming patent protection on Omnicef (cefdinir) out to 2011, although the basic composition of matter patent for the drug expires in May next year.

Lupin won approval for a capsule formulation of cefdinir, which accounted for around 37% of Omnicef’s 2005 sales.