Perrigo confirms ANDA filing for generic Astepro nasal spray

US generic drugmaker Perrigo (Nasdaq: PRGO;TASE) says that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, the US subsidiary of Sweden’s Meda (OMX: MEDA A), the owner of the New Drug Application for the branded version, Astepro, of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories (Nasdaq: IPXL), which will share costs and benefits of this project.

On January 19, 2012, Meda Pharmaceuticals filed suit against Perrigo in the US District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Last month, the US Patent and Trademark Office (USPTO) issued a patent related to Astepro (azelastine) nasal spray. This patent, which will be listed in the FDA's Approved Drug Products List (the Orange Book), is valid until 2028

Astepro Nasal Spray is a prescription medicine for people 12 years of age and older and is approved to treat nasal symptoms caused by seasonal allergies or environmental irritants. Annual sales were approximately $114 million annually, as measured by Wolters Kluwer Health.