tiated in the U.S. These patent litigations have been settled. Specialty Care Ophthalmology Lucentis: Patent protection for the active ingredient in Lucentis expires in 2018-22 in Europe and Japan. Novartis licensed Lucentis from Genentech for development and commercialization outside the U.S. Neuroscience Gilenya: Patent protection for fingolimod, the active ingredient in Gilenya (licensed from Mitsubishi Tanabe Pharma Corporation), is expected to expire in 2019 in the U.S. (including a 5-year patent term extension), and in 2018 in Europe and Japan (including a 5-year patent term extension). In Europe and Japan, the company has regulatory exclusivity for the data generated for approval of Gilenya until 2021, which could possibly be extended by one year in Europe. A patent for the commercial formulation of Gilenya has been granted in most major markets (including Australia and Russia, where there is no compound patent). This patent would expire in 2024 in most countries, including Europe and Japan, and in 2026 in the U.S. Exelon: Exelon capsules are subject to generic competition in major markets, including the U.S. and all of Europe. The company holds a patent on a specific isomeric form of the active ingredient used in Exelon that expires in 2014 in the U.S. Exelon Patch is covered by a formulation patent expiring in 2019 in major markets. In 2013, the European Patent Office granted a patent (expiring in 2026) covering a dosage regimen of Exelon Patch. Comtan: Patent protection for entacapone, the active ingredient in Comtan, licensed from Orion, has expired in Europe and the U.S. and generic versions of Comtan are available. Stalevo: Stalevo is protected by additional patents expiring up to 2020. Patent litigation by Orion in the U.S. against generic manufacturers settled and generic versions of Stalevo were launched in the U.S. Novartis was not a party to the U.S. litigation. Integrated Hospital Care Neoral/Sandimmune: Patent protection for the cyclosporine ingredient of Neoral/Sandimmune has expired worldwide. Myfortic: There is no patent protection for the active ingredient in Myfortic. Patents covering the formulation would expire in 2017. In the U.S., four patent litigations have been settled and a generic version of Myfortic is available. Generic manufacturers are seeking approval for generic versions of Myfortic in some European countries. Ilaris: Patent protection for the active ingredient in Ilaris is expected to expire in 2024 in the U.S. and in Europe. Critical Care TOBI Podhaler: There is no patent protection for the active ingredient, tobramycin. Patents covering the commercial product would expire from 2018 to 2022 in the U.S. and Europe. Additional patent applications are also pending with respect to the commercial product in the U.S. and Europe. If the last-filed of these applications were granted, then that patent would expire in 2025. In addition, in Europe, the product is entitled to orphan drug status until 2021 for the current approved indication. Compounds in Development The company has file patent applications on its Compounds in Development during the course of the development process. AIN457: Patent protection for secukinumab, an anti-IL-17 monoclonal antibody, is expected to expire in 2028 in the U.S. and 2030 in Europe. RLX030: Patent protection for the serelaxin molecule (human relaxin-2) has expired and the patents covering the formulation and process will expire shortly after the product's projected launch date. A patent covering the method of using serelaxin to treat acute heart failure has been granted in the U.S. and expires in 2029. This use patent is under examination worldwide in markets that permit use patents. Serelaxin is entitled to post-approval regulatory exclusivity for 12 years in the U.S., 11 years in Europe and 8 years in Japan. SOM230: Patent protection for pasireotide, including patent term extensions, is expected to expire in the U.S. and Europe in 2026. ALCON This division researches, develops, manufactures, distributes, and sells eye care products and technologies to serve the life cycle of eye care needs.
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