Sandoz Launches Generic Lovenox

Sandoz began launching generic versions of Sanofi-Aventis’ Lovenox (enoxaparin) in the U.S. immediately following FDA approval of the first low molecular weight heparin generic, the Novartis unit confirmed July 27.

The quick drug shipments following the July 23 approval reflect how critical it is for Sandoz to expeditiously launch the blood thinner while it has a monopoly on the generic market. Teva and Amphastar both have similar ANDAs for enoxaparin pending at FDA, though the agency has yet to act on them.

Sandoz would not disclose the price of the drug, but said “The price of enoxaparin will be significantly lower than the price of Lovenox and will provide significant cost savings.” Nonetheless, with Sandoz being the sole supplier of the generic, it’s not likely price erosion will be substantial. Information on the wholesale acquisition cost of the generic was about equal to that of the brand, according to Elsevier’s Gold Standard ProspectorRx, although the pricing data do not take into account discounts, rebates or other incentives.

Some analysts and payers speculate the price will fall somewhere in the range of 10 percent to 15 percent below the brand initially, though pricing could fall lower. “We think a 20 percent to 25 percent discount to brand accounting for all discounts and incentives would be normal,” speculated CLSA analyst David Maris. Read more.