Ribavirin is an antiviral agent used in the treatment of chronic hepatitis C virus infection that also shows activity against respiratory syncytial virus (RSV). In the United States, ribavirin is FDA-approved and marketed as inhalation solution for treating of RSV infection, and as oral capsule and tablet for the treatment of hepatitis C virus infection.
Ribavirin for intravenous administration is of limited availability, produced by ICN Pharmaceuticals/Valent Pharamceuticals International for compassionate use under an investigational new drug application. The only present FDA-approved indication for these products is in conjunction with interferon against chronic hepatitis C with hepatic damage and inhalation solution for treatment of RSV.
Taking into account multiple brands, generic preparations and variable doses, the exact cost of ribavirin is problematic to report. On the whole, the generic preparations are less expensive than the brand drugs. Rough estimates say that a 12-week course of generic ribavirin is in the range between 550 and 850 US dollars.
Known brand names
Rebetol represents the brand name for the Schering ribavirin, whereas Copegus is the brand name for the Roche ribavirin. Both of these drugs are oral formulations, available as 200 mg tablets and indicated (in a combination regimen with peginterferon alfa-2b or interferon alfa-2b) for the treatment of chronic hepatitis C virus infection. Furthermore, they are comparable in terms of efficacy.
PENDOPHARM, a division of Pharmascience Inc. based in Quebec (Canada), recently put Ibavyr to the market – the first stand-alone oral ribavirin for the treatment of chronic hepatitis C virus infections in Canada. This drug will enable certain patient groups to receive an all-oral therapy (i.e. without interferon injections), which is a novel treatment approach in Canada.
One of the most commonly known brand names of ribavirin is Virazole. Virazole for inhalation solution is a lyophilized, sterile powder which is reconstituted for aerosol administration. In this form each 100 mL glass vial contains six grams of ribavirin, thus when reconstituted to the recommended volume of 300 mL with sterile water, the final concentration contains 20 mg of ribavirin per mL with pH approximately 5.5.
Translational Therapeutics Inc. is an Arlington-based biopharmaceutical company that received orphan drug status from the U.S. Food and Drug Administration (FDA) in 2011 for its lead drug candidate in the treatment of aggressive follicular, medullary and anaplastic thyroid carcinoma. Its designation is TRX-201, and it is essentially ribavirin-elaidate – an elaidic acid ester derivative of ribavirin.
International availability and patent expiration
Notable manufacturers of ribavirin in the USA are Essex-Schering-Plough Pharmaceuticals, ICN Pharmaceuticals/Valent Pharamceuticals International in Costa Mesa, California (a place where ribavirin was discovered) and Three Rivers Pharmaceuticals in Cranberry Township, Pennsylvania. In Europe, Hoffmann-La Roche in Switzerland is the main player in ribavirin production.
Many pharmaceutical companies manufacture ribavirin in People's Republic of China. The most notable ones are Chengdu Diao Group Jiuhong Pharmaceutical Co., Ltd in Chengdu, Sichuang, China National Medicines Guorui Pharmaceutical Co., Ltd in Beijing, Jiangsu Lianshui Pharmaceutical Co., Ltd in Lianshui, Jiangsu, Siping Juneng Pharmaceutical Co., Ltd in Siping, Jilin, and Zhejiang Zhebei Pharmaceutical Co., Ltd in Deqing Xinshi, Zhejiang.
The patent for ribavirin in the United States expired in September of 2001, which opened the door for generic ribavirin. Its production and sale emerged in 2005, with three main companies sharing the cake – Teva Pharmaceutical Industries, Sandoz and Warrick Pharmaceuticals (which is a generic arm of Schering-Plough).