As announced in a detailed report into the subject area, US court has ruled that the product patent covering Prevacid in the US is valid and enforceable, leaving Teva unable to launch a generic equivalent until May 2009. Although sales of Prevacid are still expected to decrease due to strong market competition, Takeda will look to maintain its market presence by launching a follow-on product.

Prevacid (lansoprazole) is a PPI (proton pump inhibitor), which is marketed by TAP Pharmaceuticals, a joint venture between Takeda and Abbott, in the US. It is one of a handful of blockbuster drugs used to treat GERD (gastroesophageal reflux disease) and acid-related disorders. In 2006, Prevacid achieved total brand sales of around $3.7 billion, down from $3.8 billion in 2005 amid intense competition from AstraZeneca’s market leading PPI Nexium (esomeprazole), one of the most heavily marketed products in the US. Datamonitor has forecast the decline in Prevacid sales to continue prior to patent expiry, based on the effect of persistent strong marketing from AstraZeneca for Nexium. The total PPI market in the US was worth around $13 billion in 2006, forming 94% of the upper GI disorder market.

The major product patent covering Prevacid in the US is 04628098 and protects the product in this lucrative market until May 2009. Teva filed an ANDA (Abbreviated New Drug Application) for a generic version of Prevacid with the FDA. The generics company had challenged the product patent on the grounds that it was invalid. However, a US District Court Judge did not agree and sided in favour of Takeda and Abbott. Teva was hoping for a positive ruling from the court after it successfully won its challenge against the product patent of Wyeth’s Protonix (pantoprazole) —another PPI used for upper GI disorders— late in 2007.

Datamonitor believes this recent court ruling will be a positive indicator that early entry of lansoprazole generics is unlikely and that future appeals will not be successful. We do not envisage generic lansoprazole entering the US until patent expiry, unless Teva decides to launch an “at-risk” generic of Prevacid.

Takeda and Abbott, meanwhile, have announced that their joint commercial venture will split and Takeda will regain its full commercial rights to Prevacid in the US. With only a year before Prevacid’s patent expiry, Takeda has been looking to maintain its presence in the PPI market and the company looks set to follow on from Prevacid with TAK-390MR, which it filed for approval with the FDA in January 2008.

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