Not so fast, Teva. The generics giant--which last week said it was set to roll out copies of Pfizer ($PFE) blockbuster Celebrex--now has to put those plans on hold, as per a U.S. appeals court ruling.
On Tuesday, a Richmond, VA-based court reversed an FDA decision that had bestowed 180-day exclusivity on the Israeli drugmaker. That move will put it outside the first group of filers--which includes Mylan ($MYL) and Watson, now part of Actavis ($ACT)--and prevent it from bringing its version to market until June.
In this case, Teva ($TEVA) was a victim of its own punctuality. The Petah Tikva-based pharma was actually the first to file its Celebrex generic with the FDA, later striking a deal with Pfizer after it lost a patent infringement suit. But because of a quirk in the Hatch-Waxman Act linking exclusivity to particular patents, rather than drugs themselves (that's since been revised, by the way), the Fourth Circuit panel decided the FDA's decision to grant Teva exclusivity wasn't legal.
Now, Teva will find itself behind the rest of the pack of copycats ready to cash in on the $3-billion-a-year arthritis med. Celebrex is Pfizer's fourth-largest overall seller behind Lyrica, the Prevnar franchise and Enbrel, and it rings up the vast majority of its global sales in the U.S.
The setback could further depress 2015 top-line estimates that already hit below analysts' expectations. Last week, the company said foreign exchange rate fluctuations, competition to its version of AstraZeneca's ($AZN) Pulmicort and generic rivals to lead product Copaxone would keep net revenues between $19 billion and $19.4 billion for the year, below the $20.1 billion Wall Street predicted. The financial picture could worsen, too, if those Copaxone copies hit before September.
But on that front, Bank of Jerusalem Brokerage, for one, isn't worried. The FDA's "slackness" in approving Copaxone competitors from teams of Novartis' ($NVS) Sandoz and Momenta Pharmaceuticals, and Mylan and India's Natco Pharma "is looking more like winter hibernation than an afternoon nap," research head Jonathan Kreizman wrote in a Tuesday review seen by Israeli newspaper Globes.
"We are getting a strong impression that the FDA plans to continue its procrastination on the question of approving a generic version of Copaxone," he wrote. "While the main threat of competition with Copaxone comes from orally administered drugs, Teva's clock is ticking more slowly than ever, and greatly reduces the generic risk for Copaxone."
- read the court's opinion (PDF)
- get more from Globes
Special Report: Top 10 generics makers by 2012 revenue - Teva