Decks cleared for Orchid to market anti-infectives in US

CHENNAI - Decks have been cleared for the city-based Orchid Chemicals and Pharmaceuticals for marketing the generic versions of Zosyn antibiotic, with a US district court rejecting rival Wyeth Laboratories’ motion for a restraint on the sale of the drug.

Wyeth had filed a suit in the District Court of Columbia against the US Food and Drug Administration’s (FDA) decision to grant Orchid permission to sell generic Zosyn, chemically Piperacillin-Tazobactam, claiming the drug could harm critically ill patients.

The court Thursday rejected Wyeth’s motion that sought a temporary injunction against the sale of the generic version of the anti-infective.

“Wyeth has failed to demonstrate a likelihood of success on the merits of its claim that the USFDA’s approval of Orchid’s ANDAs (abbreviated new drug application) violated applicable US statutes,” Orchid Chemicals said in a statement here Friday.

Wyeth had enjoyed the patent protection for its drug Zosyn till 2008.

Orchid got the permission to sell the drug in 2.25g, 3.37g and 4.5g vial as well as 40.5g (pharmacy bulk package) dosage forms.

According to an Orchid spokesperson, no other generic company had filed application to market the drug owing to the complexities involved in making the combination injection.

He said the company has already launched the drug in the US in tie-up with Canadian company Apotex.

Orchid managing director K. Raghavendra Rao told IANS: “The addressable market for the dosage form for which Orchid Chemicals got the USFDA’s sanction is around $450 million.”

Orchid has already launched the drug in Australia, Europe and Canada.

–Indo Asian News Service