Lupin files challenge to Roche's Rocephin in USA

Indian drug company Lupin Laboratories has filed for US approval of ageneric version of Roche's cephalosporin antibiotic Rocephin (ceftriaxone), which was the latter company's biggest-selling drug last year. US patent protection for Rocephin expires in 2005, but the latest development is not unexpected, given the current focus on litigation to gain early entry for generic drugs, according to analysts.

Sales of Rocephin grew just 1% overall in 2001 to reach 1.7 billion Swiss francs ($1.01 billion), but a return to fortunes in the first quarter of this year saw the product put in a 27% sales increase (Marketletter April 22).

Analysts at Julius Baer noted that the challenge to Rocephin came as expected, but pointed out that an emerging situation in Italy may actually be more damaging for the company in the near term. In a conference call held to unveil the firm's first-quarter results, Roche revealed that the Italian government is considering reducing the patent term for Rocephin by one year. This could be a big hit to Rocephin, as Italy is its second biggest market and the patent is set to expire in 2004, according to Julius Baer.