Patent Expiry of High Impact Drugs*

To view this page ensure that Adobe Flash Player version 9.0.124 or greater is installed.

Please login or register to make a comment!

P P a a t t e e n n t t E E x x p p i i r r y y o o f f H H i i g g h h I I m m p p a a c c t t D D r r u u g g s s * * When a generic version of a high impact drug becomes available, there is substantial cost savings for drug plans. Generic drugs are usually marketed at a price at least 30-40% lower than their brand-name equivalent. Hence, patent expiry dates of high impact drugs are of interest to all payers.

Table 1 shows the patent expiry dates for the top 10 drugs in the 2001 ESI Canada/CAPSS book of business, as of July 5, 2002. There may be multiple patent expiry dates for a drug. Patents protect against copying product characteristics such as manufacturing process, ingredient, formulation or colour.

Bill C-91 gives brand name drugs an effective 20-year patent exclusivity. However, there is a process for generic companies to appeal a drug 9s patent exclusivity through Health Canada and subsequently through the court system. Table 1: Patent expiry dates for the top 10 ... more. less.

drugs ranked by drug costs 3 2001 Drug Cost Ranking Brand Treatment Latest Patent Date 1 Losec Ulcer/Reflux 2014 2 Lipitor High Cholesterol 2016 3 Paxil Depression 2016 4 Celebrex Arthritis 2017 5 Vioxx Arthritis 2014 6 Xenical Obesity 2017 7 Pantoloc Ulcer/Reflux 2006 8 Prevacid Ulcer/Reflux 2010 9 Celexa Depression 2011 10 Zocor High Cholesterol 2003 Historically, new classes of drugs are developed to replace older classes facing patent expirations. For example, H-2 antagonists such as Tagamet and Zantac were the standard of care to treat ulcers in the 1980s. However, a few years before Tagamet 9s patent expiry, a new class of drugs called proton pump inhibitors (PPIs) was introduced, led by Losec. They soon replaced the H-2 antagonists as the standard of care for ulcer prevention and treatment. However, no new or improved class of drugs is ready to replace the PPIs. PPIs like Losec, Pantoloc and Prevacid are all in our top 10 drug cost list and account for $23 million or 6% of total drug costs. Pantoloc 9s patent does not expire until 2006, which is the earliest among the PPIs. This month, a new PPI called Pariet becomes available in Canada. Although this is a brand name product, its cost will be 32-41% less than the other PPIs. Since generics of most high impact drugs may not be available in the near future, plan sponsors may need to consider other means to manage increasing costs. Drug choice management programs, such as promoting the use of cost-effective products in the same drug class may seem reasonable. In addition, active promotion of health, wellness and disease management to decrease occurrence of ulcers, depression, obesity and high cholesterol may decrease the need to use these high impact drugs. * Portions of this Newsflash were presented at the ESI Canada/CAPSS Pharmacy Outcomes Conference on May 22, 2002. For more information, visit www.esi-canada.com . 2 2 0 0 0 0 2 2 J J u u l l y y 1 1 2 2 Volume 4 Issue 11 Written by: Katherine Ho, M.Sc. Phm. Editor: Steven A. Semelman, Pharm.D.

less