AstraZeneca AB, already a defendant in several Nexium lawsuits involving the drug’s alleged association with kidney disease and renal failure, recently filed a legal claim of its own. According to documents pending in the U.S. District Court, District of New Jersey, the company has accused a generic manufacturer of infringing on two patents it holds for the popular heartburn medication.
In a filing dated July 21st, AstraZeneca alleges that the infringement occurred when Aurobindo Pharma Ltd submitted an application to the U.S. Food & Drug Administration (FDA) seeking approval of its esomeprazole magnesium delayed-release capsules. It also submitted a certification to the FDA asserting AstraZeneca’s patents are “invalid, unenforceable, or will not be infringed” by the sale of the generic versions.
AstraZeneca maintains that the two patents won’t expire until May 25, 2018, while pediatric exclusivity relating to the patents expires on Nov. 25, 2018.
“Plaintiffs will be substantially and irreparably harmed by the infringing activities described above unless those activities are precluded by this Court,” the lawsuits states. “Plaintiffs have no adequate remedy at law.”
Nexium was approved by the FDA in 2001, and belongs to a class of medications called proton pump inhibitors. These drugs are approved to treat GERD, peptic ulcers disease and other gastric disorders by preventing the release of acid in the stomach. AstraZeneca also markets an over-the-counter version of Nexium called Nexium 24HR. In 2010, Nexium was the best-selling prescription drug in the U.S. with sales of $5.3 billion.
In recent months, several Nexium lawsuits have been filed on behalf of patients who experienced serious kidney complications, including acute interstitial nephritis, chronic kidney disease and renal failure, allegedly related to their use of the proton pump inhibitor. Other drugs in this class have been named in similar lawsuits. The litigation was preceded by the publication of several studies suggesting that the extended use of proton pump inhibitors might damage the kidneys.
Proton pump inhibitors have become an extremely popular class of medications, and millions of people rely on both prescription and over-the-counter versions to obtain relief from heartburn symptoms. However, the drugs are not indicated for long-term use. According to one study, some 70% of patients prescribed these drugs have no real medical need for the medications, or continue using proton pump inhibitors when it is no longer necessary.
Bernstein Liebhard LLP is offering free legal evaluations to individuals who were diagnosed with serious kidney problems following treatment with Nexium or another proton pump inhibitor. To learn more, please call (888) 994-8177.