HYDERABAD : Drug major Dr Reddy’s Laboratories Ltd (DRL) Friday said it has launched a generic version of Allegra-D, used to relieve symptoms caused by common cold, flu or allergies, in the US market.
As per IRI data, the said Allegra-D 12 HR Allergy and Congestion extended-release tablets brand and generic had US sales of approximately $44 million for the 12 months ending May 2019. Allegra-D 12 HR is a trademark of Aventisbu II Inc.
DRL’s tryst with Allegra is over a decade old. In September 2009, the pharma firm found itself in legal cross hairs with Albany Molecular Research and Sanofi over alleged patent infringement relating to the manufacturing process for the active ingredient in Allegra, Allegra-D 12 and Allegra-D 24 HR.
It won the lawsuit and later in 2011, DRL’s abbreviated NDA for a generic of Allegra-D 12 Hour Allergy & Congestion became the first to be approved by the US Food and Drug Administration (FDA).Allegra-D 12 Hour is a combination of antihistamine fexofenadine and sympathomimetic pseudoephedrine, used for seasonal allergic rhinitis with nasal congestion.
The launch of fexofenadine HCI 60 mg and Pseudoephedrine HCI 120 mg extended-release tablets USP, an over-the-counter store-brand equivalent of Allegra-D 12 HR Allergy and congestion extended-release tablets, in the US market was approved by the US FDA, DRL said.