Boehringer Ingelheim’s arthritis drug Mobic is facing generic competition from several generic rivals in the USA following the expiry of the patent on the drug earlier this week.
The US Food and Drug Administration approved a number of copycat versions of the 7.5mg and 15mg formulations of the drug, from the likes of Teva, Mylan, Par Pharmaceuticals, Lupin Laboratories and Caraco.
In a statement, Teva said Mobic (meloxicam) US sales were around $1 billion in the 12 months ended March 2006, opening up a lucrative market for the generics houses. Teva and the other generics houses said they would start shipping their versions immediately, to there is expected to be a dramatic fall-off in sales of the brandname drug in the latter half of 2006.
The approval of meloxicam was the result of a ‘cluster’ review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications.
The agency’s Office of Generic Drugs recently began to review groups of applications submitted at the end of five-year new chemical entity (NCE) exclusivity in groups to increase efficiency and decrease the review time, with the result that more copycat versions tend to arrive on the market at the same time.