In November, the District Court of Delaware granted a temporary restraining order preventing Indian drugmaker Dr Reddy’s Laboratories from selling or distributing its version of AstraZeneca’s proton pump inhibitor (PPI) drug Nexium (esomeprazole magnesium).
But the generics firm is now poised to relaunch the product in the US, albeit with a change of colour from purple to blue.
“The colour change was made only with objective of resuming sale of the product in the fastest possible time,” a Dr Reddy spokesman told this publication.
“The colour change was made in a manner that complies with all FDA regulations and the Company will continue to sell the product in its new presentation.”
Nexium has been subject to generic competition in the US since January 2015, but while the first wave of copycat drugs were blue and white (made by Teva and Mylan respectively), Dr Reddy’s version launched in September was the same colour that AstraZeneca has used to brand its gastrointestinal products for treating severe heartburn and acid reflux – Nexium and Prilosec - since 1989.
This led to AstraZeneca taking legal action, and according to the court memorandum filed in November Dr Reddy’s was culpable of trademark infringement, and granted the temporary restraining order:
“Given the totality of the circumstances, including the physical appearance of DRL's other generics (distinctive), the fact that DRL is a second wave generic in this market (and perhaps has to be more aggressive to get market share), and DRL's explanations for adopting an all-purple pill (which the court will discuss below), the court concludes that DRL intended to test AZ's trademark, rather than honor it.”
According to the Dr Reddy’s spokesman, “the litigation concerning appropriateness of the injunction continues.”
On a side note, in July Dr Reddy’s changed its corporate colour from orange to purple.