Abbott sues Teva to try and keep it’s generic Testosterone gel off US pharmacy shelve
Abbott sues Teva to try and keep it’s generic Testosterone gel off US pharmacy shelves
An Abbott Laboratories unit accused generic drugmaker Teva Pharmaceuticals USA in a lawsuit of patent infringement with plans to market a copy of Abbott’s AndroGel testosterone preparation.
Abbott is asking a judge to block U.S. sales of the drug by Teva until the patent expires in 2021, according to an April 29 complaint filed in federal court in Wilmington, Delaware.
Without such an order, “plaintiffs will be substantially and irreparably harmed by Teva’s infringement,” lawyers for Abbott contend in court papers.
The Abbott Park, Illinois-based drugmaker said in a statement April 29 it received approval from the U.S. Food & Drug Administration to sell the 1.62 percent prescription gel formulation, used to treat adult men with hypogonadism, or lack of testosterone.
The condition, affecting nearly 14 million U.S. men, can result in hair loss, erectile dysfunction, decreased sexual desire and depression, according to the statement.
The case is Abbott Products Inc. v. Teva Pharmaceuticals USA Inc., 11-cv-384, U.S. District Court, District of Delaware (Wilmington).
Abbot gets FDA for new stronger Androgel
Abbott announced today that the U.S. Food and Drug Administration has approved AndroGel 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses.Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low or no testosterone, also known as hypogonadism.
Once a drug becomes generic those no more money to be had in it. Costs for FDA approvals and submissions and the amount of manpower that requires is outrageous.
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