Specialty pharmaceutical company
said after the market close Thursday that it will take
to court for alleged infringement of the patents regarding heartburn reliever Zegerid.
Santarus said the lawsuit, filed in the U.S. District Court in Delaware, comes in response to an abbreviated new-drug application (ANDA) filed by Par with the Food and Drug Administration for a generic version of Zegerid.
Santarus says such a generic drug would infringe on three patents in the FDA's Orange Book, in which the agency publishes patent information on approved drugs. Joining in the litigation as a co-plaintiff is the University of Missouri, licensor of the patents, which Santarus says expire in 2016.
The company received notice of a paragraph IV certification against the patents for Zegerid on Aug. 7. In order for Par to submit an ANDA for a generic version of Zegerid, it had to file the paragraph IV certification, listing the patents that are either unenforceable or not infringed by the generic drug. Santarus then had a 45-day window to file an infringement suit and slow the generic's approval process.
Santarus said it commenced the lawsuit within the 45 days required, automatically barring the FDA from approving Par's ANDA for 30 months or until a District Court decision that is adverse to Santarus, whichever may occur earlier.
Zegerid sales in the second quarter more than doubled year over year, supporting Santarus' net sales of $18.8 million compared with $8.7 million in 2006 and helping to narrow the company's net loss to $12.9 million, or 25 cents a share. That's compared with a loss of $16.7 million, or 36 cents a share, in the comparable 2006 quarter.
Santarus shares edged down a penny, or 0.6%, to $2.68 in after-hours trading Thursday. Par slid 37 cents, or 1.8%, to $19.89.