Launch of Allegra Refrained by the US Court
An opening restriction has been granted to Sanofi Aventis and Albany Molecular Research by the District Court in New Jersey, US, considering the launch of generic version of allergic medicine, Allegra D24 by Dr Reddy's Laboratories Ltd.
The petition was in relation to Dr. Reddy's condensed new drug application to promote the generic version of Allegra D24, indicated for disorders associated with various allergies.
The grant hence specifies that till the final legal resolution of the issue, Dr. Reddy’s will not be allowed to launch its Allegra in the US market.
The proposal was filed by Sanofi Aventis and Albany Molecular Research in the third week of March, subsequent to when the Hyderabad-based company attained a sanction from the US Food and Drug Administration for the generic drug.
According to the release, Dr. Reddy’s robustly differs from the Court's decision and proposes to appeal.
The Company is fully prepared for the launch of the drug in the US. A Company functionary stated: “With this latest legal development, it may not be possible to launch the drug immediately. We are working on the legal modalities to proceed further”.
As per the estimates of the industry, Allegra has a market size of $180 million in the US.