Dr Reddy’s rules out settlement for Allegra generic

Pharma major Dr Reddy’s Laboratories will have to continue to wait to take its limited-competition generic Allegra to the US market. The district court of New Jersey has granted an interim injunction on DRL’s product in response to a motion moved by the drug’s innovator Sanofi Aventis and Albany Molecular.

With the interim injunction, DRL will have to put on hold its plans to launch the drug in the market. Allegra-D 24 Hour is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Allegra-D 24 Hour tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine for extended release. Fexofenadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Though DRL said that it “strongly disagrees with the court’s decision and intends to appeal”, sources tracking the developments said that the company would first be stopped from proceeding with its plan and then will have to rework on the entire plan since it is now stuck in the courts.

“DRL did not go in for a settlement with the innovator like it did in some of the other cases. Though the FDA had allowed the company’s to go ahead with the product on March 16, it was only in May the innovator sought a legal remedy. Even if the innovator had not moved the courts, DRL would have launched the product at risk,” the source said.

In fact, Dr Reddy’s was waiting for about 30 months for regulatory approvals after filing its application with the US authorities. After the FDA gave its approval, the company was planning to launch the product in the current quarter. Though the company has officially announced that it would go in for an appeal on the injunction, sources said that there was still no clarity on the timeline and the resources that would be needed to take the product to the market. “The legal teams are still working and it would take some time before there is clarity on the way ahead,” an official said.