Article preview from "PharmAsia News" November 11, 2008
Read about why AstraZeneca, the maker of world's second largest selling drug brand Nexium (esomperazole) is going all out to protect the patent covering its popular anti-ulcer medicine.
Article preview from "PharmAsia News" November 11, 2008
AstraZeneca Guards Nexium Patent, Takes Teva, Cipla To New Jersey Court
AstraZeneca, the maker of world's second largest selling drug brand Nexium (esomperazole) is going all out to protect the patent covering its popular anti-ulcer medicine.
AstraZeneca has sued the world's top generic drug maker Teva along with India's Cipla at the New Jersey District Court alleging infringement of its U.S. patent filed for esomeprazole.
In its petition dated Oct. 9, AstraZeneca asserted that Teva engaged in activities toward infringement of its patent by submitting an abbreviated new drug application seeking U.S. FDA's approval to commercially manufacture, use and sell in the U.S. its proposed 20 mg and 40 mg esomeprazole magnesium delayed-release capsules.
AstraZeneca also indicts Cipla saying it has and will continue to aid, abet, induce, contribute to and engage in activities directed towards and otherwise participate in the infringement of the same patent by submitting a Drug Master File seeking U.S. FDA approval to commercially manufacture, use and sell bulk esomeprazole to be used in Teva's capsules. "Cipla is jointly and severally liable for any infringement of the '070 patent," AstraZeneca said in its petition.
Cipla has arrangements with more than 10 generic drug companies operating in the U.S. for supplies of key ingredients. When contacted by PharmAsia News, a senior Cipla official confirmed that Cipla has been made party in the esomeprazole case but the company is still studying the implications."
AstraZeneca submitted to the court that the '070 patent was issued on Aug. 12, and will expire on May 25, 2018 while pediatric exclusivity relating to the same patent will expire on Nov. 25, 2018.
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