NEW YORK — Sanofi-Aventis SA, France’s leading drug maker, has sued the US Food and Drug Administration in a bid to make it withdraw its clearance of a lower-cost rival to the company’s Lovenox blood thinner.
Sanofi wants a judge to force the FDA to suspend its approval of the generic produced by Novartis AG’s Sandoz unit with Momenta Pharmaceuticals Inc.’s technology. Lovenox, an injection that helps prevent blood clots, was Sanofi’s number two product last year, after the diabetes medicine Lantus.
Novartis, of Basel, Switzerland, and Momenta, a biotechnology company in Cambridge, Mass., won US approval for a lower-cost copy of Lovenox last Friday, ending a five-year wait to challenge the $3.9 billion-a-year product.
In its complaint, Sanofi said the generic is not clinically equivalent to Lovenox, and the FDA’s decision may cause Sanofi irreparable harm.
Momenta’s stock fell $3.25, or 13 percent, to $22.86. The shares had risen 9.8 percent on Friday and 4.4 percent Monday following the FDA clearance of the generic drug.
The path for approval of the generic drug was cleared when Sanofi’s patent was voided. In April 2009, the US Supreme Court left intact a lower court ruling that the patent was not enforceable because Sanofi had misled the US Patent and Trademark Office. The court rejected Sanofi’s appeal, seeking reinstatement of the patent, which could have prevented competition until 2012.
On Monday, a federal judge said he would hold a hearing Aug. 17, Momenta said. The court did not place any restrictions on the sale of the generic drug, according to Momenta.
A different federal judge in Washington yesterday threw out a suit Sanofi had filed over the FDA’s decision to approve applications for generic forms of its anticancer drug Eloxatin.
