Chennai-based Orchid Chemicals & Pharmaceuticals Ltd (Orchid) is looking at sales of $100 million with the US Food and Drug Administration granting it a six-month marketing exclusivity for Piperacillin-Tazobactum, the generic version of Wyeth’s Zosyn, in the US market. The market for this product in the US alone is estimated to be around $450 million annually.
The company, which has been hit hard by the global meltdown, feels that the approval from USFDA would help boost its top line as well as bottom line substantially in the next two quarters (October-March). “We expect an EBITDA margin of 35% alone from this ‘exclusitivity’ of six months and hope that this product will boost our top line as well as bottom line well,” said Ch Ram, head of investors relations, Orchid Pharma.
To a specific question on net sales during the period, he said: “We cannot quantify exact sales at this point of time. But being the only player other than the innovator, Wyeth, Orchid is looking at substantial revenues from this 6-month period, which will augur well for the company’s growth in the current fiscal.” The USFDA also granted an approval in favour of Orchid on the Citizen Petition move by Wyeth, he said.
Orchid has already launched these generic products in the European markets, which have an annual potential of $300 million. “After the Cephalosporin range of products, Piperacillin-Tazobactum will be the next big revenue earner for Orchid,” he maintained.
K Raghavendra Rao, managing director, Orchid Chemicals, said, “This is a great milestone in our US generics journey. Our product is not only the first generic one to be approved but also has ben granted 180-day generic drug exclusivity. These approvals demonstrate Orchid’s technological and regulatory skills. Given the premium nature of this life-saving antibiotic and our first generic status with exclusivity, we anticipate a significant contribution to our revenues and profitability in the ensuing quarters.”
The FDA approval covers Orchid’s generic equivalents in 2.25g, 3.375g and 4.5-g vials as well as 40.5 g (pharmacy bulk package) dosage forms and strengths. Orchid will market the products in the US through its partner Apotex.
