ICN Drug Could Face Generic Rival

ICN Pharmaceuticals Inc.’s ribavirin drug, used in combination with a Schering-Plough Corp. drug to treat hepatitis C, may face generic competition within a year if an unidentified company wins Food and Drug Administration approval for its version.

The FDA’s Web site said the agency has received a request from a company to sell a generic version of ribavirin, which is sold by Schering-Plough with its own hepatitis C drugs Intron A and Peg-Intron. ICN of Costa Mesa receives royalties, which totaled $155 million last year.

The FDA doesn’t disclose the names of companies that apply to sell generic drugs.

The filing certifies patents on the drug as either invalid or not infringed by the generic version. That certification can be challenged in court by Schering-Plough. The company has 45 days after being notified of the application to sue.

“We are considering our legal options but aren’t commenting further,” said Bob Consalvo, a spokesman for Schering-Plough, who said the company received notice of the generic application in the past week.

The push to bring a generic version of the drug to the market isn’t surprising, Consalvo said, because the company’s period of FDA-granted exclusivity on the drug runs out in December.

If Schering-Plough sues, the court battle will focus on whether five patents held by Schering-Plough and ICN would be infringed by a generic version of ribavirin, which is sold as Rebetol by Schering-Plough.

Those patents expire beginning in 2016, meaning generic competition could be kept at bay for more than a decade if a court finds that copycat drugs infringe those patents.

Separately, ICN said the European Union granted it a new patent covering how ribavirin is manufactured for use in treating three types of viruses, including the hepatitis C liver disease. The patent has been issued in Austria, France, Germany, Great Britain, Italy, the Netherlands, Sweden and Switzerland.

ICN stock fell $1.22 to $28.98 a share on the New York Stock Exchange. Schering-Plough stock fell 24 cents to $37.64 a share.