Ranbaxy Laboratories suffered a stinging setback in its battle to keep rival copies of AstraZeneca's ($AZN) heartburn med Nexium and Roche's ($RHHBY) antiviral Valcyte off the market. A U.S. court denied its request for a temporary restraining order against other companies that want to produce generic versions of the drugs.
U.S. District Judge Beryl Howell in Minneapolis, MN, turned down Ranbaxy's request to stop Endo International ($ENDP) and Dr. Reddy's Laboratories from moving ahead with plans to market their copies of the drugs, an order the India-based company sought as part of a lawsuit it filed last week against the FDA, Bloomberg reports.
The agency recently revoked tentative approvals for Ranbaxy to make its own Nexium and Valcyte generics based on manufacturing problems found at two of its Indian facilities in 2006 and 2008. The FDA's move blocked "hundreds of millions of dollars in anticipated revenue," the company said in a complaint seen by Bloomberg. Analysts had estimated generic Nexium would add about $150 million to Ranbaxy's overall sales in the first 6 months of its launch, and generic Valcyte would contribute around $50 million, Reuters reports.
On Valcyte, the FDA already yanked Ranbaxy's 180-day exclusivity, earned because it was first to file for approval of its generic. That immediately opened the door for would-be makers of Valcyte copies. For now, the agency is staying mum on whether it will do the same with Ranbaxy's exclusivity on Nexium, which went off patent months ago.
The court order does not bode well for Ranbaxy, as it struggles to gain ground after regulatory setbacks and quality issues at some of its Indian plants. Earlier this year, the FDA put the kibosh on exports from the company's active pharmaceutical ingredients (API) facility in Toansa, and the agency has banned four of Ranbaxy's 5 approved plants.
|Sun Pharmaceutical Managing Director Dilip Shanghvi|
Meanwhile, fellow Indian drugmaker Sun Pharmaceutical Industries agreed earlier this year to snatch up Ranbaxy for $3.2 billion in an all-stock deal. Sun's Managing Director Dilip Shanghvi told Reuters at the time of the deal that his main priority was getting Ranbaxy's operations back on track, even before cutting costs. The sale is expected to close by the end of this year.
Ranbaxy continues to push for approval of generic versions of blockbuster drugs. In June, the drugmaker enjoyed a bright point when the FDA finally cleared its generic of Novartis' ($NVS) Diovan for launch. In September, Connecticut Attorney General George Jepsen signed onto a Citizen's Petition urging the FDA to approve Ranbaxy's generic Nexium or waive the 180-day exclusivity that prevents other generic drugmakers from jumping into the market.
Special Report: Top 10 drug patent losses of 2014 - Nexium