In a fresh jolt to Dr Reddy’s Laboratories, a US court has directed the pharma major to temporarily stop selling its generic version of Esomeprazole in the American market.
According to a statement issued by the company, the US District Court of Delaware issued the order based on a motion moved by AstraZeneca objecting to the usage of the colour purple in the generic version of Nexium (Esomeprazole).
“The order has been passed pending further hearing of trial. The court has asked the parties to propose a next course of action and submit the same to the court. The court shall conduct a telephonic status conference on Thursday, November 12, 2015,” the drug maker said.
AstraZeneca argued that the Purple Pills (Prilosec and nexium) have been famous for many years through extensive advertising both to doctors and patients, industry-leading commercial success, and extensive publicity, among other reasons.
“On an average annual basis since 1995, AZ has spent over USD 250 million building its purple brand,” AZ argued.
Dr Reddy’s, which launched the generic version ofu00a0Nexium, used to treat acid reflux, in the US market on September 25, said it is complying with the court’s order and simultaneously evaluating all possible options to resolve the matter at the earliest.
A DRL official said that the company has initiated talks with its US counterparts and may submit a report to the court as directed.
He, however, said the stocks that are lying in the market may not have any impact with the court’s order.
Nexium and generic version had sales of approximately USD 5.2 billion in the US for most of recent 12 months ending in July, 2015.
“Defendant’s actions, as described above, including without limitation the use and promotion of the purple generic esomeprazole magnesium capsule are likely to cause confusion, or to cause mistake, or to deceive as to the origin, sponsorship, or approval of Defendant, its products, and/or its commercial activities by or with AZ, and thus constitute trademark infringement, false designation of origin, passing off, and unfair competition in violation of…” AstraZeneca said in its petition.
Several companies have recently entered the market with generic prescription versions of the Nexium (esomeprazole magnesium compound).
The first two companies permitted by the FDA to sell generic versions of Nexiumu2014Teva and Mylanu2014use blue and white capsules for their respective generics, the company further argued.
The development comes on the heels of the US Food and Drug Administration directing the pharma company to get a third party assessment of its three manufacturing plants for which it received warning letter last week.
DRL said that it was in the process of shifting some of the products to other plants in the wake of warning letters.
The country’s second largest drug maker last week said it received a warning letter from the US drug regulator relating to two of its Active Pharma Ingredients (API) manufacturing plants and a Formulation plant located in Andhra Pradesh and Telangana.