GENERIC DRUG TRENDS
Increases in Drug Utilization and Patent Expirations: A Recipe for Growth of Generics’ Market Share, despite Stalling on Biosimilars Dalia Buffery, MA, ABD
s 2009 is coming to a close, the future of generics appears brighter than ever, with many brand-name medications pending patent expiration by 2011, accounting for about $34 billion in total sales in 2008.1 The drug patent expiration outlook
Table Drug Patent Expiration, 2009-2011 Potential patent 2008 US sales, Brand (generic) expirationa $ million 2009 Adderall XR (amphetamine salts) 1585 Ambien CR (zolpidem controlled-release) 986 777 CellCept (mycophenolate mofetil)b Clarinex (desloratadine) 251 Prevacid (lansoprazole) 2948c Pulmicort Respules (budesonide) 876 Topamax (topiramate) 2356 Valtrex (valacyclovir) 2020 2010 Aldara (imiquimod topical cream) 375 Arimidex (anastrozole) 617 Astelin (azelastine nasal spray) 273 Cozaar (losartan) 731 282 Differin (adapalene topical)b Effexor XR (venlafaxine extended-release) 2791 1318 Flomax (tamsulosin)b Hyzaar (losartan/hydrochlorothiazide) 548 Mirapex (pramipexole) 344 2011 Aricept (donepezil) 1224 2569 Actos (pioglitazone)b Caduet (amlodipine/atorvastatin) 418 Levaquin (levofloxacin) 1719 Lipitor (atorvastatin) 6392 Patanol (olopatadine ophthalmic 256 solution)b Temodar (temozolomide) 224 Xalatan (latanoprost ophthalmic solution) 494 Zyprexa (olanzapine) 1853 a
These dates can change for many reasons, including patent protections/litigation or exclusivities. expiration assumes a pediatric extension. Sales figure apply to the capsule formulation only. Source: Medco 2009 Drug Trend Report. 2009, page 53. bPatent c
AMERICAN HEALTH & DRUG BENEFITS
overshadows the recent Senate vote to extend the patent exclusivity period for biologics to 12 years, as requested by the biotechnology industry, thereby significantly delaying the introduction of potential biosimilars to the market. A biosimilars pathway now seems likely to become a reality by 2010 or 2011. Nevertheless, with drug costs doubling in the decade between 1996 and 2006, as was recently shown in a new report from the Agency for Healthcare Research and Quality (AHRQ),2 and the continuing trend of growing utilization of generics in the United States, the growth in first-time generics will likely continue to rise (even if at a lower rate than before), further increasing the competition with brand-name products and possibly contributing to their price inflation, especially after 2011.1 According to the AHRQ report, “Prescription medications accounted for a notably higher share of total expenses for adults ages 18-44 in 2006 than in 1996 (17.6 percent versus 10.2 percent),”2 and “The average expense for a prescription medication purchase was notably higher [for that age group] in 2006 than in 1996 ($161 versus $79).”2 Similarly, Medco projects an increase in health plan drug utilization between 2009 and 2011 (from 0%-1% to 1%-2%, respectively) and in drug price (from 3%-4% to 4%-5%, respectively) per member per year,1 all pointing to the continuing trend of greater generics utilization in the coming years. A select list of brand-name drugs expected to lose their patent by 2011, as well as their US retail sales in 2008, is listed in the Table. Many of these drugs will likely appear as generics by 2011. If by then a biosimilar pathway becomes available, as is widely anticipated in the industry, the total utilization rate of generics/biosimilars and their share of the total market are likely to increase even further. ■ References 1. Medco Health. Medco 2009 Drug Trend Report. 2009. http://filecache.drivetheweb.com/mr4enh_medco/177/2009+DRUG+T REND+REPORT.pdf. Accessed December 9, 2009. 2. MEPS. AHRQ. Trends in Health Care Expenditures for Adults Ages 1844: 2006 versus 1996. Statistical Brief #254. August 2009 (available December 9 only). www.meps.ahrq.gov/mepsweb/data_files/publications/ st254/stat254.pdf. Accessed December 10, 2009.