Two big drugmakers will slug it out in a federal court in Newark at 11 am EST. The row is over Lotrel, a high blood pressure pill that generated $1.3 billion in US sales last year for Novartis, which also owns Sandoz, the generic company.

On Friday, Teva received FDA approval to sell its copycat and immediately shipped the med. Then, on Saturday, a US District Court Judge in New Jersey granted a Novartis request for a restraining order, which required Teva to recall all generic Lotrel that had been shipped.

As The Orange Book Blog notes, Novartis and Teva have been locked in litigation over Teva’s generic Lotrel since 2004. The 30-month stay expired earlier this year and, probably sensing that Teva was close to obtaining final approval (and fearing an at-risk launch), Novartis moved for a preliminary injunction in March. The court was set to hear arguments on that motion in July.

A Novartis win this morning could delay the launch of generic Lotrel until either a court ruling in the ongoing litigation (although no trial date has been set) or the expiration of the Lotrel patent in 2017, AG Edwards’ analyst Joe Toomey writes in an investor note this morning. He adds that a loss of exclusivity could cost Novartis $600 million in sales this year.

Further reading:

Teva press release;
Novartis TRO;
Restraining order;
The Orange Book Blog.[tags]Generics, Lotrel, Novartis, Patents, Teva Pharmaceuticals[/tags]