Reuters reports that the Food and Drugs Administration (FDA) has granted tentative approval to Teva Pharmaceutical's application to market generic ribavirin (see notice on FDA's website). Teva’s generic ribavirin will join three other generics already on the market, from Three Rivers Pharmaceuticals, Sandoz, and Warrick Pharmaceuticals (Schering-Plough’s generic subsidiary). Final approval will presumably come in October, upon the expiration of the 180-day marketing exclusivity period awarded by the FDA to Three Rivers and Sandoz (for background, see my earlier post, Generic Ribavirin Price Alert).
Teva’s tentative approval signals the potential for increased pricing competition for generic ribavirin. Back in April, prior to the introduction of generic ribavirin, the “branded” versions (Schering-Plough’s Rebetol and Roche’s Copegus) were significantly more expensive than today, based on prices from drugstore.com:
In April, Rebetol cost about $9 for a 200 mg capsule – at 1,200 mg/day, that added up to over $1,600 for a 30-day supply, or $18,300 for a full 48 weeks.
In April, Copegus cost about $6 for a 200 mg capsule – at 1,200 mg/day, that added up to over $1,000 for a 28-day supply, or $12,300 for a full 48 weeks.
Today, drugstore.com offers generic ribavirin for about $4.30 for a 200 mg capsule – at 1,200 mg/day, this adds up to just under $800 for a 30-day supply, or about $8,700 for a full 48 weeks.
That’s still a lot higher than necessary for a drug that was first developed over 30 years ago and is relatively cheap to manufacturer. But it’s progress – and hopefully more competition will drive the price even lower. And private insurers and government payers such as Medicaid typically aren't paying full retail price – they negotiate lower prices and rebates with the companies.
Unfortunately, the overall cost of hepatitis C treatment will remain high, driven by the expense of the pegylated interferons. Tomorrow I’ll write about prospects for generic versions of interferon.