Last March, it looked as if Pfizer ($PFE) would have plenty of breathing room before generic competition to its blockbuster arthritis pill, Celebrex. That was when the U.S. patent office reissued a key patent, extending Pfizer's market exclusivity to the end of 2015. But this March, a U.S. court struck down that decision, suddenly opening the drug up to copycat rivals.
Now, that competition has arrived. The FDA gave the green light to Celebrex copies from Teva Pharmaceutical ($TEVA) and Mylan ($MYL). Teva will retain exclusive marketing rights to three doses of the drug for 180 days, while Mylan has a 6-month exclusive on the smallest dose. Celebrex (celecoxib) was Pfizer's fourth-biggest hit last year, with sales of $2.9 billion.
Mylan is not happy that Teva will reap most of the generic sales of Celebrex out of the gate. The Pittsburgh-based drugmaker sued in April to try to prevent the FDA from granting exclusivity to Teva. But on Friday, the U.S. District Court for the Northern District of West Virginia denied Mylan's request for an injunction. Mylan is appealing that denial, according to a press release the company issued today.
Mylan did confirm in its release that it reached a settlement and license agreement with Pfizer, which will allow Mylan to market generic versions of all four doses by December of this year. But the company isn't conceding to the delayed release. "Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on celecoxib and will continue with this suit independent of the aforementioned settlement," the company said in the release.
As for Teva, it settled with Pfizer in late April, reaching an agreement that will allow it to launch generic Celebrex this December or sooner. Generics maker Actavis ($ACT) was also part of that settlement. Just when all these generic rivals will hit the market remains to be seen, but one fact is all but certain: Generic drugs are often priced 30% to 80% lower than their branded counterparts, according to the Associated Press, so it likely won't be long before Celebrex is no longer on Pfizer's best-sellers list.
- access Mylan's press release here
- here's the AP story
- read more at RTT News
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