Orchid Chem gets US nod to sell generic antibiotic
16 Sep 2009
Pharmaceuticals manufacturer Orchid Chemicals Ltd today announced that the US Food and Drug Administration has granted it a 180-day marketing exclusivity for its generic antibiotic piperacaillin-tazobactam.
The FDA has approved multiple injectible forms of the drug, which is a generic version of Wyeth's Zosyn.
"We anticipate a significant contribution to our revenues and profitability from this product in the ensuing quarters," K Raghavendra Rao, managing director of Orchid Chemicals, wrote in filing with the Bombay Stock Exchange.
Orchid will launch these drugs immediately in the US in partnership with Canada's Apotex Inc. The market size for these dosage forms in the United States is estimated at $450 million, Rao said.
The approval was delayed as Wyeth challenged the equivalence of Orchid's drug to the original product through a citizen's petition with the FDA, Rao separately told Reuters. The regulator had ruled in favour of Orchid, he added.
