Blockbusters Coming Off Patent in 2013

This page describes just a few of the drugs facing patent expiration in 2013. For an explanation of the contents of this catalog, finding other years or products, copyright information, and more, go to the Catalog Index.

Cymbalta (duloxetine HCl)

After a tumultuous approval that included manufacturing difficulties, Lilly's duloxetine HCl is now FDA-approved for depression, generalized anxiety disorder, diabetic nerve pain and fibromyalgia, and under trial for osteoarthritis, adult ADHD, migraine, phantom limb pain, chronic fatigue syndrome and more. Off-label uses have been reported for stress incontinence, bipolar disorder, and irritable bowel syndrome, among others. With this potential spectrum of patients, Lilly has already sued several firms, including Wockhardt, Impax, and Sandoz for patent infringement of its second-biggest seller.

Humalog (insulin lispro)

Lilly's insulin lispro for control of Type 1 & 2 diabetes was the first approved insulin analog. Its bioengineering offers larger amounts of monomeric insulin to be available for postprandial injection, a contrast to - and tremendous advantage over - traditional insulin. Patent battles have been fought with Beijing's Gan & Lee already - no surprise with the almost 8% of the US population already diagnosed with diabetes, a number that is only expected to rise.

Abreva (ducosanol)

Developed by BioSolutions and marketed by GlaxoSmithKline, ducosanol 10% cream is the only FDA-approved OTC treatment for cold sores, and was the first OTC anti-viral. The product has captured approximately 40% of sales of the OTC lip remedies in the U.S. and has also been licensed in Canada, Korea, Israel, and some Middle-Eastern countries. Studies are also reported to be planned to evaluate the product for use in genital herpes, making it a potential blockbuster ripe for patent challenge.

Rescriptor (delavirdine mesylate)

Pfizer's delavirdine mesylate is approved for treatment of HIV-1 infection when used in combination with at least two other antiretroviral agents. Off-label, it has been used for postexposure prohylaxis to HIV infection in individuals exposed to the virus. While no patent challenges are yet making the news, 23 clinical trials have been launched or completed to evaluate the drug's potential in various combinations, making it clear there is considerable post-patent interest.

Iressa (gefitinib)

AstraZeneca's gefitinib was approved by FDA in 2003 for certain small non-small cell lung cancers, a year after its approval in Japan. In 2004, doubts were raised about efficacy and calls for market removal were heard saying there was no significant survival advantage in the product. Labeling restrictions followed. By 2008, however, it had emerged that the product is effective in EGFR mutation positive patients, making it an early example of genome-based therapy, information on which has even been incorporated in the 2009 EU-approved labeling. Iressa's patent was successfully challenged in India, but seems to be holding its own in the U.S. The patents (and market) most worth watching may be in Asia, where the EGFR+ mutation is most commonly seen.


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Byetta (exenatide)

Also taking advantage of the huge and growing market for diabetes therapies is Lilly's exenatide, approved to treat Type 2 diabetes by enhancing the release of endogenous insulin from the pancreas. Lilly is developing a long-acting-release formulation to replace the current twice-daily injection and reduce side-effects, which could take the sting off the sales hit sure to happen when Byetta's patents expire. Exenatide has been used off-label for Type 1 diabetes, weight-loss, and diabetes prevention for those believed to be at risk. It is in clinical trials for burn healing, post-myocardial infarction, and Prader-Willi Syndrome.

Viracept (nelfinavir mesylate)

Pfizer's protease inhibitor, used in treatment of HIV infection in conjunction with other antiretrovirals, has been used off-label for HIV postexposure prophylaxis and herpes. Experimentally, it is being tested in various cancers, tuberculosis, and additional combination therapies for HIV. When introduced to the market, Viracept was the 12th approved antiviral, but broke all previous biotech sales records, bringing in US$335 million in its full first year. A European manufacturing problem hurt 2007-2008 momentum and sales, and a new venture to combine forces with former market leader GlaxoSmithKline has been formed to increase Viracept's share of the $12.3 billion HIV market now dominated by Gilead Sciences.

When you click on a button with a drug name, you'll generate a listing of titles of the original approval documentation and related early documents about the product. Double-click on any title for more information, including NDA number, price, document size and more.

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