Bayer HealthCare and Meda Pharmaceuticals have filed a patent infringement suit against Apotex after Apotex submitted an ANDA for a generic version of Astepro Allergy azelastine hydrochloride nasal spray, 0.15%. The FDA approved Bayer’s NDA for Astepro Allergy for non-prescription treatment of allergic rhinitis in June 2021. According to the complaint filed by Bayer and Meda, both companies received notification of the submission from Apotex at the end of August.
Astepro was initially approved by the FDA as a prescription drug in 2008, and Meda filed a patent infringement suit against Apotex related to a generic of that version of Astepro in January 2012. The agency approved Apotex’s generic later that year.
Meda, which is now part of Viatris, and Bayer, which has an exclusive license to market Astepro Allergy, allege that the new Apotex submission infringes on US Patent No. 8,071,073 (“Compositions Comprising Azelastine and Methods of Use Thereof”), which expires in June, 2028; US Patent No. 8,518,919 (“Compositions Comprising Azelastine and Methods of use Thereof”), which is set to expire in November 2025; and US Patent No. 9,919,050 (“Compositions Comprising Azelastine”), which expires in July 2026.
