Bayer, Meda sue Apotex over nasal spray
Bayer Healthcare and drug importer Meda Pharmaceuticals have sued generic manufacturer Apotex, alleging that its planned generic nasal spray infringes on Bayer’s Astepro (azelastine) patents.
The complaint, published by the US District Court for the District of Delaware on Thursday, asks the court to block Apotex from manufacturing the steroid-free allergy nasal spray until the expiration of three patents.
The patents-in-suit are US patent 8,071,073, 8,518,919, and 9,919,050. The ‘073 has the furthest expiration date, with an adjusted expiration of June 2028.
The patents cover “compositions comprising azelastine”, which is used to alleviate or prevent various allergy symptoms.
Apotex had applied for an Abbreviated New Drug Application (ANDA) seeking approval to manufacture and market a generic of the azelastine hydrochloride nasal spray with the Food and Drug Administration.
As part of the process, Apotex notified Bayer that it had submitted the ANDA in August 2021, writing in the letter that the related patents were invalid.
Bayer and Meda are seeking a judgment that each of the patents has been infringed by the ANDA and a preliminary or permanent injunction barring Apotex from marketing its generic.
Bayer recently had a challenged claim of its targetted cancer drug Sorafenib invalidated at the English High Court in a dispute with Israeli pharmaceutical company Teva Pharmaceuticals.
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