U.S. Patents for Nicox’s Latanoprostene Bunod, Commercialized as VYZULTA®, Eligible for Patent Term Extension
April 22, 2021
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the United States Patent and Trademark Office (USPTO) has determined that three U.S. composition of matter patents covering latanoprostene bunod, commercialized as VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, are eligible for patent term extension, potentially through to 2030.
The initial patent term of the latanoprostene bunod patents concerned is 2025. Nicox believes that each of these patents could be extended by almost the maximum 5 years allowable. The duration of this patent extension is subject to calculation by the U.S. Food and Drug Administration (FDA) with the final decision of the USPTO regarding the term of the extension expected in two to three years. Nicox would then select one of the three patents for the extension.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said “VYZULTA was launched in the United States in December 2017 by our exclusive global licensee Bausch + Lomb. The extension of the patents covering this product would ensure a long-term revenue source for the company and solid support for future value as we continue the development of our clinical assets NCX 470 in glaucoma and NCX 4251 in blepharitis.”
Latanoprostene bunod, the pharmaceutical active ingredient in VYZULTA, was invented and patented by Nicox, and is the first product from the company’s proprietary nitric oxide-donating research platform to be approved for commercialization. Under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the “Hatch-Waxman Act”) certain patents for pharmaceutical products in the U.S. may be extended by up to 5 years once product approval from the FDA has been obtained.
VYZULTA is commercialized in the U.S. (since 2017), Canada (2019), Argentina (2020), Mexico (2020) and Hong Kong (2020), and is now approved in 5 other territories (Brazil, Colombia, South Korea, Taiwan and Ukraine). VYZULTA is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication. Bausch + Lomb, which is planning to launch VYZULTA in Taiwan and in South Korea, will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities.
Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of VYZULTA plus up to $150 million in potential future milestone payments.