A U.S. district court temporarily barred Dr. Reddy’s Laboratories from selling its generic version of AstraZeneca’s Nexium (esomeprazole) in the U.S., the company said Tuesday. The order was passed by the U.S. district court of Delaware after AstraZeneca moved a motion objecting to the use of the colour purple in Dr. Reddy’s product. The Indian company noted that the restraining order has been imposed “with immediate effect.”
“The company is complying with the order of the court and simultaneously evaluating all possible options to resolve the matter at the earliest,” Dr. Reddy’s commented. The order is pending further hearing or trial, while the court has asked the drugmakers to propose a course of action to resolve the matter. The court is scheduled to conduct a status conference on November 12.
Dr. Reddy’s launched its generic version of Nexium in the U.S. in September after a district court declined a request by Sun Pharmaceutical’s Ranbaxy unit to block the US approval of other generic versions of the drug last year.
Nexium, including its generics, amassed US sales of about $5.2 billion for the 12 months ended last July. Dr. Reddy’s anticipates $50 million in annual revenue for its product, while analysts at Bank of America previously estimated that generic Nexium could boost the Indian drugmaker’s 2016 fiscal year profit by $25 million to $35 million.
The news comes after Dr. Reddy’s received a warning letter from the FDA earlier this month regarding deficiencies identified at three of its manufacturing facilities in India. The company later estimated that the action would depress revenue by 10 percent to 12 percent.
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