Par Pharma launches generic Ultram ER in US
This article was originally published in Scrip
Par Pharmaceutical has gained final US FDA approval of its extended-release tramadol product in 100mg and 200mg strengths, a generic version of Ortho-McNeil's (Johnson & Johnson) once-daily Ultram ER. Following the approval on November 13th, Par immediately began shipping the analgesic, with the launch date marking the beginning of 180 days of exclusivity (granted as a result of its first-filer status).
Purdue Pharma is the holder of two US patents for the controlled-release product, and earlier this year a US district court ruled in Par's favour in its challenge of the validity of those patents (scripnews.com, August 21st, 2009).
At that time, Labopharm said that Ultram ER, and any generic version of it, was not AB-rated to its own once-daily version of Ultram ER, Ryzolt, meaning that it could not be substituted for Ryzolt at the pharmacy. The launch of any generic tramadol product, however, could affect all of the branded tramadol products.
Annual US sales of Ultram ER in 100mg and 200mg strengths are about $156 million, according to IMS Health.