Businessweek

Teva Pharmaceutical Industries Limited, a pharmaceutical company, develops, manufactures, markets, and distributes pharmaceuticals in the United States and Europe. The company’s business includes three primary areas, including generic, specialty, and over-the-counter (OTC) medicines. Product Offerings GENERIC PRODUCTS The company manufactures and sells generic pharmaceutical products in various dosage forms, including tablets, capsules, ointments, creams, liquids, injectables, and inhalants. It offers a range of basic chemical entities, as well as specialized product families, such as sterile products, hormones, narcotics, drugs, and cytotoxic substances, in both parenteral and solid dosage forms. The company produces approximately 300 active pharmaceutical ingredients for its own use and for sale to third parties in various therapeutic areas, including respiratory, cardiovascular, anti-cholesterol, central nervous system (CNS), dermatological, hormones, anti-inflammatory, oncology, immunosuppressants, and muscle relaxants. SPECIALTY PRODUCTS The company’s specialty medicines business, which is focused on delivering solutions to patients and providers through medicines, devices, and services in primary regions and markets worldwide, includes various core franchises, medicines for CNS disorders (with an emphasis on multiple sclerosis (MS), neurodegenerative disorders, and pain) and respiratory medicines. The company also has specialty products in oncology (including biologics), women’s health, and other areas. Its specialty business also includes its emerging new therapeutic entity activity, which focuses on improving known molecules through new delivery methods, combinations, or device innovations to address specific patient needs. CNS The company’s CNS portfolio includes Copaxone for the treatment of MS, Azilect for the treatment of the symptoms of Parkinson’s disease, and Provigil and Nuvigil for the treatment of sleep disorders, as well as various novel therapies for the treatment of pain. Copaxone (glatiramer acetate injection), the company’s primary specialty medicine, is the MS therapy worldwide and is approved and marketed in approximately 50 countries, including the United States, all European countries, Russia, Canada, major Latin American markets, Australia, and Israel. Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS, including in patients who have experienced a first clinical episode and have MRI features consistent with MS. The company’s MS portfolio consists of Copaxone, as well as laquinimod, a Phase III compound under development. In the United States, the company has Orange Book-listed patents relating to Copaxone with terms expiring in May 2014, as well as a non-Orange Book patent expiring in September 2015. Additionally, it has patents expiring in May 2015 in the rest of the world (ROW). The company also holds patents protecting various aspects of the process of preparing Copaxone and methods of analyzing this product, which expire between 2019 and 2024. Copaxone is subject to various patent requirements in the United States and Europe. Provigil (modafinil) is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). Outside the United States, Provigil is approved under various trade names in approximately 30 countries, including France, the United Kingdom, Ireland, Italy, and Germany, for the treatment of excessive daytime sleepiness associated with narcolepsy. In certain of these countries, it also has approval to market Provigil to treat excessive sleepiness in patients with OSA and/or SWD. Nuvigil (armodafinil), the R-isomer of modafinil, is indicated for the treatment of excessive sleepiness associated with narcolepsy, OSA, and SWD. Following the positive results of a Phase II clinical trial of Nuvigil as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder, Cephalon, Inc. (Cephalon) (the company’s subsidiary) initiated three Phase III clinical trials. Nuvigil is protected by various patents, the