Dr.Reddy’s Laboratories Ltd on Tuesday said it got a restraining order from a US court against selling a purple-coloured generic version of Astra Zeneca Plc’s heartburn pill Nexium, also known as the purple pill.
The British drug maker approached the US district court objecting to the usage of the colour purple in Dr.Reddy’s generic version of Nexium.
“The district court of Delaware, US, granted a temporary restraining order with immediate effect on sales, delivery, transfer, or other disposition of its generic esomeprazole product in the US market,” the company said in a statement. “The order has been passed pending further hearing or trial.”
Dr.Reddy’s said it is “complying with the order of the court and simultaneously evaluating all possible options to resolve the matter at the earliest.”
Nexium, known chemically as esomeprazole, is a proton pump inhibitor used to reduce acid in the stomach to treat gastroesophageal reflux disease (GERD).
Dr.Reddy’s launched 20 milligram (mg) and 40 mg capsules on 25 September.
The regulatory problems at the Srikakulam plant have delayed the company’s launch of its version of Nexium by around three quarters.
Generic Nexium was approved by US Food and Drug Administration (USFDA) in September only when Dr Reddy’s shifted supply of the drug’s APIs to another plant.
Dr.Reddy’s said WHEN it’s expecting more than $50 million from sales of generic Nexium in the next 12 months.
Nexium had branded and generic sales of approximately $5.2 billion for the 12 months ended July, according to US-healthcare information provider IMS Health.
Dr.Reddy’s on Thursday said it has received warning letter for its active pharmaceutical ingredient (API) manufacturing plants at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, and an oncology formulations facility in Visakhapatnam (Andhra Pradesh).
The company said it is in the process of preparing a comprehensive remediation plan to be submitted in 15 days, as was stipulated by the USFDA.
Shares of Dr.Reddy’s extended losses for a third consecutive trading session, declining 1.45% to Rs3336.30 on BSE, while the exchange’s benchmark Sensex dropped 1.45% to 25,743.26 points.