Bayer’s Astepro Allergy was approved by the US Food and Drug Administration (FDA) for nonprescription use back in June. Bayer claims it is the first over-the-counter, steroid-free antihistamine allergy spray available in the US.
The complaint filed on Thursday asks the US District Court for the District of Delaware to delay the FDA’s approval of Apotex’s generic drug until the final Astepro patent expires in 2028. The complaint also requests that Apotex is blocked from producing it before this date, and a 30-month stay of approval process is initiated by the lawsuit under the Hatch-Waxman Act.
FDA approval was granted to Meda for the prescription version of Astepro in 2009. In a statement, Bayer spokesperson Chris Loder said that the company licences the patents from Meda and maintains the right to enforce them against alleged infringers.
The suit by Bayer and Meda follows Apotex’s filing of an Abbreviated New Drug Application (ANDA) for FDA approval of its generic drug. An ANDA declares that the relevant drug patents are either invalid or would not be infringed by the generic drug. It opens the applicant to infringement claims from the patent owner.
The complaint claims that Apotex told the FDA that the relevant parts of the patents were not valid.