Generic Versions of Hepatitis C Drug Approved

FDA Approves 2 Generic Forms of Ribavirin for Hepatitis C Treatment

Medically Reviewed by Brunilda Nazario, MD on April 08, 2004
From the WebMD Archives

April 8, 2004 -- The FDA has approved two new generic versions of a drug that's a mainstay of hepatitis C treatment.

Yesterday, the FDA approved generic versions of the drug ribavirin, which until now has been sold under the brand name Rebetol by Schering-Plough and Roche.

Ribavirin is typically used in combination with interferon for the treatment of chronic hepatitis C. Experts say the approval of generic versions will likely reduce the cost of chronic hepatitis C treatment, which currently costs up to $25,000 per year.

Infection with the hepatitis C virus is a leading cause of liver disease in the U.S. and the No. 1 cause of liver transplants. It affects about 4 million Americans. Hepatitis C infection can lead to cirrhosis and liver cancer. More than 30,000 new cases are diagnosed each year.

The hepatitis C virus is most commonly transmitted via contact with contaminated blood through sharing needles or other medical equipment. It may also be transmitted through sexual contact with an infected individual.

Generic Hepatitis C Drugs Approved

Sandoz Inc., a subsidiary of Swiss drug maker Novartis, and Three Rivers Pharmaceuticals both received approval from the FDA to market their copycat versions of ribavirin for the treatment of chronic hepatitis C.

Three Rivers Pharmaceuticals plans to sell its drug under the name Ribasphere, and Sandoz will sell its version under the name Ribavirin Capsules.

Although the companies did not disclose how much the new generic versions would cost, generic drugs usually cost much less than their brand-name counterparts. In addition, the introduction of generic versions of a drug usually drives down the cost of the name-brand version.