This page describes just a few of the drugs facing patent expiration in 2010. For an explanation of the contents of this catalog, finding other years or products, copyright information, and more, go to the Catalog Index.
Eisai's treatment for Alzheimer's-related dementia sells approximately $3 billion annually, guaranteeing that a number of generic firms will be competing for the product’s market share after the November 2010 patent expiration. Candidates already announcing their plans include Mutual Pharmaceutical, URL Pharma, Roxane, Apotex, and Aurobindo; all have submitted ANDAs. Teva's ANDA has been approved since 2008 but the company lost a court battle to market its product and must wait until patent expiry.
While a pediatric exclusivity extension extended the effective patent life of Merck's hypertension treatments Cozaar and Hyzaar, the company will see generic competition in April 2010. Watch for generics from Zydus, Lek Pharma and Aurobindo, who hold tentative approvals for generic losartan.
Eli Lilly is embroiled in court battles with Fresenius and APP Pharmaceuticals over Gemzar patent expirations. At issue is the validity of two patents, one expiring in 2010 and another in 2013. While the 2013 patent was found to be invalid for obviousness-type double patenting, Lilly has appealed the decision. With few promising drugs thought to be in the pipeline and disappointing sales on its new blood-thinner, Effient, Lilly is fighting hard to keep the $1 billion in annual sales the cancer drug gemcitabine generates.
Used to treat breast, lung, prostate, stomach and head/neck cancers, docetaxel generates roughly $2 billion/year for Sanofi-Aventis. In a suit filed in October 2009, Sanofi-Aventis claims that Sandoz must wait until the last of three patents expire in 2013 before a generic version can be allowed onto the market, rather than using the date of the first patent expiry in April 2010.
Wyeth, part of Pfizer, has spent years in court defending its patents for pantoprazole to treat erosive esophagitis and other stomach acid complications. Pediatric exclusivity actually gives Protonix exclusivity through January 2011, when generics are expected from Apotex, Teva, Sun, and Kremers Urban Developments.
In a court battle begun in 2002, a U.S. District Court upheld Ortho-McNeil's claim of the validity of the Levaquin (levofloxacin) patent and ruled that it was infringed by a proposed generic levofloxacin product from Mylan Laboratories, Inc. The court ordered FDA to change the effective date of Mylan's approval to market its generic levofloxacin tablets to no earlier than the date of patent expiration, December 2010. Levofloxacin is an antibiotic used to treat a wide variety of infections.
More Information About Drug Approvals!
In these listings, we've concentrated on giving you the information of most interest to those interested in investigating potential generic market entry. For most of the drugs listed (and many others), we have even more information. To find everything we have available for a product, use the home page search box to enter the drug name.