Hanmi launches Nexium competitor in the US
This article was originally published in Scrip
AstraZeneca's blockbuster PPI Nexium (esomeprazole magnesium) has a new competitor in the US market in the form of an esomeprazole strontium product sold by Hanmi Pharmaceutical and its US marketing partner Amneal Pharmaceuticals.
The at-risk launch follows the lifting of a temporary injunction on 30 September 2013, by the US Court of Appeals for the Federal Circuit (CAFC) against Hanmi's US launch of its 505(b)(2) NDA esomeprazole strontium product (previously granted on 13 September 2013), AstraZeneca said.
The company added that its appeal of the lower court's December 2012 claim construction remains pending. A decision is expected from the CAFC in early 2014 following oral argument on 18 November 2013. The appeal concerns both patents-at-issue in the patent infringement litigation against Hanmi (US Patent Nos. 5,714,504 and 5,877,192).
AstraZeneca reckons that these developments will have no impact on its full-year 2013 financial guidance, adding that depending on the outcome of the appeal, Hanmi's sales are at risk of owing AstraZeneca patent infringement damages.
It is thought that the 505(b)(2) NDA esomeprazole strontium product is not AB-rated and is not automatically substitutable for Nexium. As such, analysts say it is unlikely to have a huge effect on sales of the brand product.
Worldwide sales of the product in 2012 were down 10% at $3.94bn with the lion's share of $2.27bn (–5%) coming from the US market. Nexium is due to lose first US patent protection in May 2014.