OK Sought for Generic of ICN Hepatitis Drug
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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 receives royalties, which totaled $155 million last year.
The FDA doesn’t disclose 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 within 45 days of its being notified of the application.
ICN shares fell $1.22 to close at $28.98 on the New York Stock Exchange.
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