Roche’s AIDS (Retinitis) & Organ Transplant Drug Going Generic?
Roche Holdings Ltd. appears to have lost some protection on Valganciclovir HCl. The FDA has granted Ranbaxy Laboratories Ltd. “tentative approval” to manufacture and market Valganciclovir Hydrochloride Tablets (450 mg).
Valganciclovir HCl Tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. Valganciclovir HCl is also indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart and kidney-pancreas transplant patients at high risk.
The estimated total annual sales for Valganciclovir HCl Tablets were $239 million Ranbaxy also noted that it believes it has “First-to-File” status on on the generic AIDS drug tablets, which would give it a potential of 180-days of marketing exclusivity.
Roche Holdings Ltd. trades in the US on the Pink Sheets under the “RHHBY” ticker, so it isn’t exactly the easiest stock to play for most investors.
Jon Ogg
June 25, 2008