Teva Pharmaceuticals (Nasdaq, TASE:TEVA) today received tentative approval from the United States Food & Drug Administration to market a cholesterol-reducing drug.
Teva's Prevastatin (sometimes spelled as Pravastatin) is the generic version of Pravachol, made by Bristol-Myers Squibb (NYSE:BMY). Sales of the proprietary version of the drug reach $1.3 billion a year.
The FDA announcement was surprising, as Bristol-Myers' patent runs out in 2005. Investec Bank analyst Kobby Finkelstein said that tentative approvals usually come a few months before the patent runs out, indicating that Teva might be able to begin marketing sooner than expected.
Finkelstein also noted that Teva is the chief supplier of raw materials to make the statin family of drugs.
At the end of the first quarter, Teva had 62 products in the FDA pipeline, which could command annual sales of $22 billion. About 30% of them are likely to receive exclusivity for six-month periods.