Containment Drug Delivery Systems FDA Approval Production 
FDA Law Blog
JUNE 13, 2024
As we explained back in March , Teva had initiated Hatch-Waxman pre-launch patent litigation against Amneal for infringement of 5 Orange Book-listed patents reading on the device constituent (a metered dose inhaler) of Teva’s combination product ProAir HFA. b)(1) that drug product patents may be listed if they claim the “drug product.
Drug Discovery World
AUGUST 9, 2023
The news followed an announcement that Biogen would be cutting around 1,000 jobs, or 11% of its workforce, to allow investment into its product pipeline.
FDA Law Blog
MARCH 12, 2024
Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.
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