Paving the path for Lupin

MUMBAI: Indian generic drugmaker Lupin may be able to launch Omnicef in the US following the US court ruling. The ruling allows generic manufacturers to sell Omnicef in the US after the first patent expires a minute before Monday, May 6.

Though Lupin was first to receive final approval, on May 26, from the US Food and Drug Administration (FDA), Abbott managed to stall a launch by filing a litigation against the Mumbai-based drugmaker in the federal court of Virginia.

According to Abbott’s filing, Lupin was using the crystalline form to make the drug, whose patent remains with Abbott till 2011.

Lupin has received approval only for 300 mg Cefdinir capsules.

“So far, the federal judge has been in Lupin’s favour,” said a source close to the company.

Lupin is now waiting for a nod from the Virginia court to launch in the US. Abbott has also started selling its own drug without the label, or as authorised generic, to prevent sales by copycat drugmakers.