This page describes just a few of the drugs facing patent expiration in 2011. For an explanation of the contents of this catalog, finding other years or products, copyright information, and more, go to the Catalog Index.
Actos is Takeda's once-daily oral medication used in the treatment of type 2 diabetes. Off-label uses described in the literature include: polycystic ovary syndrome, psoriasis, autism, colitis, and Tourette syndrome.
Purdue Pharma's Controlled Release Tablets for management of moderate to severe pain have been featured in the news frequently for abuse liability, even to the point of the media nicknaming it “Hillbilly Heroin”. After approval as a Schedule II drug, FDA added a requirement for a strict black box warning discussing the diversion potential and ease of overdose. Although prescribers are watched with special interest by the Drug Enforcement Agency, the drug's effectiveness as an analgesic, duration of action and ease of use have kept it on the blockbuster list.
This Britol-Myers Squibb/Sanofi-Aventis antiplatelet tablet is indicated for reducing the risk of stroke or heart attack in patients with certain circulatory disorders. While several legal attempts have been made to circumvent the patent and produce a generic version earlier, the patents have so far held off competition for clopidogrel.
Zyprexa has been a blockbuster for Eli Lilly, and is indicated for treatment of schizophrenia and bipolar 1; notable side effects include possible diabetes, neuroleptic malignant syndrome, and significant weight gain. In 2009, Lilly was fined a record $1.4 billion for off-label promotion of the product for indications such as dementia, sleep disorders, depression, agitation, and anorexia. In spite of the court-mandated marketing changes, olanzapine is still often used for off-label indications in the psychiatric community.
Pfizer's Xalatan (latanoprost) is a topical medication used for controlling the progressions of glaucoma or ocular hypertension by reducing intraocular pressure. As the top selling eye pressure lowering medication on the market, it has been subject to and survived several patent challenges. Annual sales are about $1.6 billion.
AstraZeneca's Seroquel, labeled for use in bipolar disorder and schizophrenia, has also been tried extensively for off-label conditions, including insomnia, PTSD, alcoholism, Tourette Syndrome and anorexia. Most recently, news reports estimate there are over 14,000 pending lawsuits involving pancreatitis and/or diabetes.