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Eli Lilly & Co. is heading to court to stop a generic drug maker from marketing an off-brand version of the popular testosterone treatment, Axiron. This latest legal battle comes as Lilly itself faces a growing number of testosterone lawsuit filings over the medication’s alleged association with heart attacks, strokes and other cardiovascular complications.
According to court documents, Eli Lilly and its partner, Australian based Acrux DDS Pty Ltd, filed suit against Lupin Pharmaceuticals Inc. in the U.S. District Court, Southern District of Indiana, charging that Lupin’s filing of an abbreviated new drug application with the U.S. Food and Drug Administration (FDA) violates Axiron’s patent protections. Lilly and Acrux claim that the patent protects Axiron from generic competition until 2026.
Axiron is a topical testosterone gel that is approved to treat testosterone deficiency in men. The drug’s patent is owned by Acrux, which licenses it exclusively to the Indianapolis-based Lilly. In 2014, Axiron’s global sales amounted to around $170 billion, or 13.7% of the worldwide testosterone market.
According to court documents, more than 1,800 testosterone lawsuits have been filed in a multidistrict litigation now underway in the U.S. District Court, Northern District of Illinois, all of which accuse Eli Lilly and other drug manufacturers of failing to warn patients that low-T therapy could increase their risk for heart attacks, stokes and dangerous blood clots. Plaintiffs also claim that Axiron, AndroGel and other name-brand treatments were wrongly marketed as remedies for low libido, fatigue and other issues associated with normal, age-related drops in testosterone. In fact, these drugs haven’t been proven safe and effective for this purpose, and are currently only approved to alleviate hypogonadism (testosterone deficiency) associated with certain underlying medical conditions.
In March, the U.S. Food & Drug Administration (FDA) ordered low-T manufacturers to add new information to their product labels regarding a potential association with heart attacks and strokes. The agency also mandated that wording on the labels clearly state that the drugs haven’t been approved to treat issues associated with aging.
If you suffered a heart attack, stroke or serious blood clot while using Axiron or another low-T product, a testosterone lawyer at Bernstein Liebhard LLP can help you decide if filing your own lawsuit would be in your best interest. To learn more, please call to schedule a free case review.