Injunction Halts Actavis’ Marketing of Generic Pulmicort
A federal appeals court issued an injunction halting sales of Actavis’ generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, just four days after the generics maker launched its version.
Actavis (formerly Watson) and fellow generics makers Breath Limited, Sandoz and Apotex are all temporarily barred from selling any more generic Pulmicort (budesonide inhalation suspension) pending appeal of a decision that invalidated the therapy’s ‘834 patent. The generics makers have until Feb. 20 to respond, according to the ruling.
Actavis launched its generic Pulmicort Respules immediately after a New Jersey district court judge ruled the patent invalid and denied AZ’s request for a permanent injunction in a consolidated challenge from the generics makers.
Tuesday’s injunction, by the U.S. Court of Appeals for the Federal Circuit, does not affect product that already shipped, Actavis says. The company’s ANDA received FDA approval in 2012.
In court documents, Actavis blasts the injunction, noting that Teva has been on the market with its own version of Pulmicort Respules since 2009 — enabled by an exclusive licensing agreement the Israeli company signed with AZ in 2008 to settle patent infringement litigation. That case was over separate patents not at issue in the current spat.
The ‘834 patent runs until 2018 and has pediatric exclusivity protection into 2019.
U.S. brand and generic sales for Pulmicort Respules, a maintenance medicine for children 12 months to 8 years, totaled about $1.1 billion in the 12 months ending June 30, Actavis said. — Bryan Koenig
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