Mylan Symbicort Trial Looms As Company Eyes First US Generic

Teva Has Previously Settled ANDA Litigation

 
• By Dean Rudge
  
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A trial will begin next month in Mylan’s bid to overcome patents shielding AstraZeneca’s Symbicort respiratory brand in the US. With rival Teva having previously settled ANDA action, Mylan is in the driving seat for a first substitutable generic.

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Mylan will face trial on Smybicort, with Teva having settled litigation • Source: Shutterstock

Mylan N.V. is gearing up for US patent-litigation action over the company’s proposed substitutable generic to AstraZeneca’s Symbicort (budesonide/formoterol) dry-powder inhaler, with the US firm “excited very soon” to have a first-to-market opportunity. A trial alleging infringement of four patents by the originator is scheduled begin in a US District Court for the Northern District of West Virginia on 13 October.

Action had been initiated by AstraZeneca in a Delaware district court in October 2018, after Mylan’s partner 3M Drug Delivery...

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