Actavis says that it will launch 0.25 mg and 0.5 mg vials of its generic budesonide inhalation suspension immediately after the United States District Court for the District of New Jersey ruled that the products do not infringe AstraZeneca’s patents on Pulmicort Respules. Actavis (then Watson) received FDA approval for its ANDA for the 0.25 and 0.5 mg strengths of the budesonide inhalation suspension in August 2012. It has also submitted an ANDA for a 1 mg product.
The court ruled US Patent No. 6,598,603, “Method for treating respiratory diseases,” is invalid and that the Actavis product does not infringe on US Patent No. 7,524,834, “Sterile powders, formulations, and methods for producing the same.”
According to Actavis, total brand and generic sales of Pulmicort Respules in the US over the past 12 months was approximately $1.2 billion. According to AstraZeneca, its US sales of Pulmicort Respules in 2012 totaled $136 million. AstraZeneca noted that it also received approximately $260 million in royalties from Teva for its generic version of the product, an amount that will be significantly impacted by Actavis’s entry into the market.
AstraZeneca Executive VP North America Paul Hudson commented, “AstraZeneca strongly disagrees with the Court’s decision. AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. AstraZeneca is considering next steps, including an appeal of the Court’s decision.”
Read the Actavis press release.
Read the AstraZeneca press release.
