ult patients at low-moderate immunologic risk receiving a kidney transplant as well as for the prophylaxis of allograft rejection in adult liver transplant recipients. Everolimus is also available from Novartis in different dosage strengths and for different uses in non-transplant patient populations under the brand names Afinitor and Votubia. It is also licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents. Ilaris (canakinumab) is a fully human monoclonal antibody that selectively binds and neutralizes interleukin-1b (IL-1b), a pro-inflammatory cytokine. Since 2009, Ilaris has been approved in approximately 60 countries for the treatment of children and adults suffering from cryopyrin associated periodic syndrome, a group of rare disorders characterized by chronic recurrent fever, urticaria, occasional arthritis, deafness, and potentially life-threatening amyloidosis. In 2013, Ilaris was approved in the EU for the treatment of acute gouty arthritis in patients who cannot be managed with standard of care, and in the U.S., EU and other countries for the treatment of systematic juvenile ideopathic arthritis. Critical Care TOBI Podhaler (tobramycin inhalation powder) is an inhaled dry powder formulation of the antibiotic tobramycin, delivered using a simple and portable patient-friendly device that reduces administration time by 72% relative to TOBI (tobramycin nebulizer solution), with comparable efficacy and safety. TOBI Podhaler was approved by the U.S. FDA in March 2013 and has been approved in the EU. It is indicated for the management of cystic fibrosis patients aged six years and older with Pseudomonas aeruginosa infection in their lungs, whose lung function is within a certain range. Markets This division sells products in approximately 140 countries worldwide, and net sales are concentrated in the U.S., Europe, and Japan. As of December 31, 2013, this division served customers with 2,439 field force representatives in the U.S. (including supervisors) and an additional 21,129 in the rest of the world. The company sells its prescription drugs primarily to wholesale and retail drug distributors, hospitals, clinics, government agencies, and managed healthcare providers. Intellectual Property Oncology Gleevec/Glivec: The company has patent protection on imatinib, the active ingredient used in its major product, Gleevec/Glivec, until July 2015 in the U.S. (including pediatric extension), until 2016 in the major EU countries and until September 2014 for the main indications in Japan with generics authorized for a minor indication expected from December 2013. Additional patents are granted in approximately 40 countries, including the U.S., Japan, France, Germany, the U.K., Italy, and Spain, claiming features of Gleevec/Glivec, including crystal form (expiry 2018), tablet formulation (expiry 2023), and process (expiry 2023). Afinitor/Votubia and Zortress/Certican. Patent protection for everolimus, the active ingredient in these products, and licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents, is expected to expire in 2020 in the U.S. and in 2018-2019 in Europe and other major countries. Exjade. Patent protection for the active ingredient in Exjade would expire in 2019 in the U.S. and in 2021 in other markets. In the U.S. and Canada, generic companies have challenged the compound patent. In the U.S., an automatic stay preventing the FDA from approving a generic version of Exjade will expire in August 2014. Novartis has begun patent litigation against this generic company in the U.S., with a trial scheduled for January 2014. Tasigna. Patent protection for the active ingredient in Tasigna would expire in 2023 in the U.S. and other major markets. Zometa and Reclast/Aclasta: Patent protection on zoledronic acid, the active ingredient in these products, expired in 2012 in a limited number of smaller markets, and in 2013 in the U.S. and in other major markets. In the U.S., generic versions of Zometa and Reclast are available. In Europe, generic versions of Zometa are launched and generic Aclasta is available in some countries.
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