Mylan Symbicort Trial Looms As Company Eyes First US Generic
Teva Has Previously Settled ANDA Litigation
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.
You may also be interested in...
Viatris and partner Kindeva Drug Delivery are celebrating a first tentative nod for a generic to one of the most significant respiratory opportunities in the US, but cannot launch at present with the firms having failed to navigate key pieces of intellectual property.
In the month ahead, a key ANDA approval could come for Viatris, while additional competition to Gilead Sciences’ Truvada for PrEP is on the way in the US following Teva and Amneal’s launches.
In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.