Auxilium Pharmaceuticals, the maker of Testim® 1%, has filed a lawsuit against Watson Laboratories Inc. and related companies for allegedly violating patents protecting its best-selling testosterone replacement gel.
Auxilium and FCB I LLC, a subsidiary of Xstelos Holdings Inc., filed the lawsuit in U.S. District Court for the District of New Jersey on May 23, accusing Watson Laboratories, Watson Pharmaceuticals, Inc. and Watson Pharma Inc. of infringing on 10 Testim® patents listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations, better known in the industry as the FDA’s “Orange Book.”
According to Auxilium, the lawsuit was prompted by Watson’s filing of an Abbreviated New Drug Application (ANDA) with the FDA for a generic 1% testosterone gel product. Watson’s intent to manufacture this new testosterone product infringes upon ten Testim® patents that won’t expire until at least April 23, 2023, Auxilium claims, with some of the patents expiring in early 2025.
Testim® is Auxilium’s top-selling drug and the cornerstone of the company’s portfolio. In 2011, Testim sales earned the company nearly $208 million, accounting for more than 78 percent of Auxilium’s total revenues. The topical testosterone-replacement drug is intended for use by men with clinically low levels of the hormone, although growing numbers of men use the product for recreational purposes, particularly as a sexual enhancement aid.
Testim shared about 20 percent of the testosterone gel market as of December 2011, but sales are expected to soar in coming years as the drug grows in popularity. Auxilium, a small company based in Malvern, Penn., also has teamed up with international pharmaceutical giant GlaxoSmithKline to increase Testim sales globally.
Testosterone-replacement drugs like Testim and Androgel, a similar product made by Abbott Laboratories, present a number of risks to men who use them to achieve excessive testosterone levels, but even non-users can suffer adverse effects through secondary contact with the drug.
The FDA warns that women and children who become exposed to Testim through contact with a user’s skin or clothing may experience virilization and other ill effects, including inappropriate development and distribution of hair, aggression, enlarged genitals, increased sex drive, and advanced bone age.
Because Auxilium filed the patent infringement lawsuit in accordance with FDA regulations, the agency cannot grant final approval to Watson’s generic testosterone drug for up to 30 months or the final resolution of the pending lawsuit, whichever comes first.
“Should Watson receive tentative approval from the FDA for its generic version of Testim before one of those events occurs, it would not be permitted to launch its generic product in the U.S.,” Auxilium said on its website. “Watson will also not be able to launch a generic version of Testim in the U.S. until it receives the necessary final approval of its ANDA from the FDA, which includes proving to the FDA that Watson’s proposed generic product is comparable to Testim in dosage form, strength, route of administration, quality, performance characteristics, and intended use,” the company added.