5 not including possible patent extension); Portrazza is protected by a compound patent (2025 not including possible patent extension), and by biologics data package protection (2027); Strattera is protected by a patent covering its use in treating attention deficit-hyperactivity disorder (2016) plus pediatric exclusivity (2017); Trajenta and Jentadueto are protected by a compound patent (2023), and Boehringer Ingelheim has applied for a patent extension to 2025 under the patent restoration laws; and Trulicity is protected by a compound patent (2024 not including possible patent extension) and by biologics data package protection (2026). Outside the U.S., primary patent protection or data protection comprises Alimta in major European countries (compound patent 2015, vitamin regimen patent 2021) and Japan (compound patent December 2015, patent covering use to treat cancer concomitantly with vitamins 2021); Cialis in major European countries (compound patent 2017); Cymbalta in Japan (data package protection 2018); Forteo in Japan (data package protection 2018; patent covering its formulation and related process 2019); and Zyprexa in Japan (patent for bipolar mania would expire April 2016). Patent Licenses The compound patent for Cialis is the subject of a license agreement with GlaxoSmithKline (Glaxo), which assigns to the company all rights in the compound. The compound patent for Alimta is the subject of a license agreement with Princeton University, granting the company an irrevocable exclusive worldwide license to the compound patents for the lives of the patents in the respective territories. Alimta is also the subject of a worldwide, nonexclusive license to certain patents owned by Takeda Pharmaceutical Company Limited. Government Regulation Pursuant to the Federal Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration has jurisdiction over all of the company’s human pharmaceutical products and certain animal health products in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, advertising, dissemination of information, and post-marketing surveillance of those products. Outside the U.S., the company’s products and operations are subject to similar regulatory requirements, including by the European Medicines Agency in the EU and the Ministry of Health, Labor and Welfare in Japan. History Eli Lilly and Company was founded in 1876 by Colonel Eli Lilly. The company was incorporated in 1901 in Indiana.
eli lilly & co (LLY:New York)
Lilly Corporate Center
Indianapolis, IN 46285
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