By Robert Dailey —

AstraZeneca and Israeli generic drug manufacturer Dexcel Pharma recently settled litigation involving the 20 mg delayed-release formulation of omeprazole (Prilosec®).  Under the agreement, Dexcel and its partner, Perrigo Company, will have the exclusive marketing rights to the store-branded OTC version of omeprazole.

In May 2006, AstraZeneca had filed suit against Dexcel after Dexcel filed a New Drug Application containing Paragraph IV certifications against three AstraZeneca  patents.  At the time of settlement, the district court had not yet made any substantive rulings in the case, although the parties had submitted a joint claim construction chart to Judge Farnan.

AstraZeneca has enjoyed over $700 million in sales of Prilosec OTC® within the past year.  The settlement will not immediately cut into this income stream, as Dexcel is still awaiting FDA approval of its NDA.  According to Perrigo (Dexcel’s partner), FDA approval is expected near the end of Q1 in 2008.

This serves as an additional blow to AstraZeneca’s efforts to maintain protection for various forms of Prilosec®.  Earlier this year, the Federal Circuit invalidated the patent covering the AstraZeneca’s process for preparing its oral formulation (see "In re Omeprazole Patent Litigation (Fed. Cir. 2007)").

For additional information regarding this case, please see:

• Perrigo Company press release
• Pharmaceutical Business Review report