Article
Author(s):
Actavis will immediately relaunch its budesonide inhalation suspension, a generic version of AstraZeneca's Pulmicort Respules, after a federal court upheld that a key patent is invalid.
Actavis will immediately relaunch its budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, after a federal court upheld that a key patent is invalid.
Pulmicort Respules is a maintenance medication indicated to control and prevent asthma symptoms in children aged 12 months to 8 years. The FDA approved Actavis’ Abbreviated New Drug Application for the generic version back in August 2012.
“We are pleased to be able to supply the market immediately with this product, and we are pleased that the Court of Appeals was able to work so swiftly to address this important matter,” said Actavis CEO and president Brent Saunders in a press release.
The appellate court also dissolved an injunction granted on March 12, 2015, that was preventing Actavis from further distributing its generic version of Pulmicort Respules.
The asthma medication had total US brand-name and generic sales of approximately $1.2 billion in 2014.
FDA Approves Ustekinumab-kfce as Sixth Biosimilar to Stelara