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Court bans sale of generic form of AstraZeneca asthma drug
17 Apr 2009
Regulatory Affairs
A US court has granted AstraZeneca's request for a temporary restraining order banning Apotex from launching a generic version of asthma treatment Pulmicort Repsules.
Canadian company Apotex will not be allowed to sell its form of the drug until further order from the court, which will begin a hearing to determine whether the injunction should be continued on April 27th.
The US Food and Drug Administration approved a generic version of Pulmicort Repsules on March 30th and AstraZeneca filed a lawsuit and request for an injunction following Apotex's indication that it intended to market its form of the drug.
AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Repsules and will continue to vigorously defend and enforce its intellectual property, the company stated.
Patents covering the drug expire in 2018 and exclusivity in the paediatric market extends to 2019.
This week, Hoffman La Roche filed a lawsuit against Mylan over attempts to market its generic version of breast and colorectal cancer chemotherapy, Xeloda, which are alleged to be a violation of intellectual property rights.
