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Published on 10/31/2005 in the Prospect News Biotech Daily.

IVAX said it intends to challenge AstraZeneca patents on Pulmicort Respules

By E. Janene Geiss

Philadelphia, Oct. 31 - IVAX Corp. said Monday that it will challenge the patents protecting AstraZeneca's preventative asthma medicine Pulmicort Respules because IVAX said it believes it was first to file an Abbreviated New Drug Application for the inhalation treatment, which is marketed by AstraZeneca for children 12 months to 8 years.

IVAX filed its application for budesonide inhalation suspension with the U.S. Food and Drug Administration in late 2004, according to a company news release.

In September, IVAX amended its application with paragraph IV certifications, alleging invalidity and non-infringement in respect to certain of AstraZeneca's patents relating to budesonide inhalation suspension, and also notified AstraZeneca of those certifications.

On Oct. 26, AstraZeneca filed suit against IVAX in the U.S. District Court for the District of New Jersey, company officials said in the release.

According to data, Pulmicort Respules had annual sales of about $561 million for the year ending June 30.

IVAX Corp., headquartered in Miami, develops, manufactures and markets branded and generic pharmaceuticals and veterinary products.


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