This page describes just a few of the drugs facing patent expiration in 2014. For an explanation of the contents of this catalog, finding other years or products, copyright information, and more, go to the Catalog Index.
Included here because of its original patent expiration in 2014, Bristol-Myers has won a pediatric exclusivity extension for aripiprazole until April, 2015...unless Teva prevails in its patent challenge initiated in 2007. Judging by the product's growth rate, watch for more patent challenges – in 2009, the product yielded $606 million – a 31% jump over the previous year. Indicated for bipolar disorders, schizophrenia, autism and as an add-on to an antidepressant, aripiprazole was recently approved for treatment of children over 10 for bipolar disorder, and the product carries the expected atypical antipsychotic black box warnings for suicidal thoughts in children and young adults.
AstraZeneca's esomeprazole, indicated for acid reflux and erosive esophagitis, has held its own in sales among other branded products such as Prevacid, and remains one of the world’s largest selling drugs. This may not last. The advent of generics for the same indications, now accounting for 40% of marketed products, have cut into Nexium’s market share for the "purple pill" – which last year amounted to $5.9 billion. The proton pump inhibitor's patent history is somewhat controversial, generating some charges that this enantiomer of omeprazole provides little advantage or change but is an attempt to "evergreen" the product. In the end, though, it's an attractive market, and AstraZeneca has already brought the Indian firm Lupin to court, alleging patent infringement. Barring successful patent challenges from other firms, the first generic on the market will be Ranbaxy, licensed in 2008 by AstraZeneca to begin distribution six months before patent expiration. Finally, esomepazole carries two patents not expiring until 2018, and the trade press has wondered if these are an ace up AstraZeneca’s patent lawyers' sleeves.
Boehringer Ingelheim's angiotensin II receptor antagonist telmisartan is approved to treat hypertension and reduce the risk of cardiovascular events. With net sales of $17 billion reported in 2008, the firm will be looking to protect and extend the patent for this first drug in its class to reduce the risk of heart attack and stroke. Even with a black box warning advising against use during pregnancy, there is huge interest in the potential of the product; over 90 clinical trials have been or are being conducted to investigate its use in various patient groups, drug combinations and for other disease states.
Genzyme's doxercalciferol, used to maintain consistent serum concentrations of vitamin D hormone, is approved for secondary hyperparathyroidism, and was acquired when the firm bought Bone Care International to gain products for kidney disease. Trials testing the drug for osteoporosis and prostate cancer are also underway. Sales, posted at $128 million in 2008, should be enhanced by the introduction of a vial formulation to replace a more awkward glass ampoule as well as a 1mcg capsule. Genzyme is actively defending its patent protections; in July 2009 the company sued the Sandoz unit of Novartis for alleged infringement.
Teva Pharmaceuticals claims two companies are violating patents on Copaxone, glatiramer acetate for Multiple Sclerosis (MS). The original suit against Momenta Pharmaceuticals and Sandoz now has expanded to include ten patents, three of which run past the expected generic drug entry of 2014…so when generics will appear is now an open question. Copaxone, approved as an orphan drug, is Teva's flagship product, with sales of over $680 million a year. In addition to being in clinical trials for various combinations, dosage rates, and administration strategies in the mitigation of MS, the drug is now also being studied for macular degeneration and Crohn's Disease.
Marketed by Pfizer, celecoxib, a COX II inhibitor, is indicated for arthritis pain, other acute pain, and primary dysmenorrhea. It is also marketed as Onsenal for familial adenomatous polyps. Available already as a generic in India and the Philippines, the drug was originally developed by Searle and co-promoted by Pfizer and Monsanto (whose research division was eventually acquired by Pfizer). Searle had already prevailed in a patent suit with The University of Rochester, and with Vioxx's market withdrawal in 2004, Celebrex enjoyed a large market share, even with a clinical trial underway investigating the cardiovascular risks now described in a black box warning. Pfizer expected patent exclusivity until 2015, but a Federal Circuit court, siding with Teva, invalidated the patent in question and resulted in the loss of approximately 18 months of patent protection for Pfizer. Watch for generics on May 30, 2014, when the pediatric exclusivity expires.