French Drugmaker Sues To Block Generic Blood-Thinner : Shots - Health News The maker of a popular brand-name medicine used to prevent blood clots is seeking a court order to prevent sales of a generic version approved by the FDA last week.
NPR logo Sanofi Files Suit To Block Sale Of Generic Lovenox

Sanofi Files Suit To Block Sale Of Generic Lovenox

Well, we sort of figured this was coming.

Sanofi-Aventis has gone to court here in Washington to prevent rival drugmaker Novartis from selling a generic version of the blockbuster blood-thinner Lovenox.

What's the problem? Well, Sanofi stands to lose big bucks. In the U.S. last year, the French company nearly $3 billion of the medicine used to combat blood clots.

Sanofi says the Food and Drug Administration didn't do a good enough job in making sure that the generic Lovenox, or enoxaparin, was equivalent to the original stuff.

"If not remedied, FDA's decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy," the company alleged in court filings, according to a Reuters report.

Lovenox is a complex mixture of sugars that act as an anticoagulant inside the body. The injected medicine is frequently prescribed to prevent clots from forming in leg veins.

Novartis' Sandoz unit partnered with Momenta Pharmaceuticals to sell the medicine, which the Food and Drug Administration approved late last week after years of legal combat. The decision was seen as a precedent that could ease the approval of other biotech-style medicines.

In a statement, Sandoz said, the company "underwent a rigorous five-year FDA approval process for enoxaparin and we are confident in FDA's actions."