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Pharmacy Times
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With expansion in the generics market and fewer FDA drug approvals, growth in dollar sales for drugs was down in 2007, though the number of prescriptions dispensed increased slightly.
Mr. Lamb is a freelance pharmacy writer living in Virginia Beach, Virginia, and president of Thorough Cursor Inc.
Overall, the number of prescriptionsdispensed in 2006 increasedslightly from 2007,growing by 103 million. Sales were up3.8% from the previous year, rising to$286.5 billion.
Generics accounted for 67.3% of the3.8 billion prescriptions dispensed in theUnited States last year, according to IMSHealth. This statistic goes a long waytoward explaining why the growth in dollarsales for drugs was the lowest since1961. Other reasons the research firmcited for the relatively static performanceof the pharmaceutical market were thatfew significant new medications wereapproved in 2007, and entire classes ofdrugs lost orders and sales due to concernsover safety and efficacy.1
Robust Performers
As it has for several years running,Pfizer Inc?s Lipitor (atorvastatin) took thetop spots on the lists of drugs prescribedand sold. Another cholesterol-loweringmedication, Teva?s simvastatin, made thebiggest leap into the top 10 of prescribedproducts by moving up from 85th placein 2006. Zocor, Merck?s branded versionof simvastatin, fell from 25th in prescriptionsand 7th in revenues during 2006 tobe completely off both lists in 2007. Thatslide began when Zocor lost patent protectionin the summer of 2007.
Generally, the ranks of the biggestearners remained unchanged. The onlysignificant newcomer to the top 20 forsales was Vytorin, which combines simvastatinand Zetia (ezetimibe; Merck/Schering-Plough). Vytorin rose from 30thto 18th in sales. How recent reports thatneither Vytorin nor its Zetia componentreduces atherosclerosis better than simvastatinalone will affect prescribing andsales remains to be seen.2
Lipid regulators were the second-mostprescribed class of drugs, led only byantidepressants. The antidepressantsgenerated 232.7 million prescriptions,whereas the lipid regulators generated220.9 million scripts. Both classes easilyoutpaced codeine and combination analgesics,which came in third, with 186.1million prescriptions.
Except in the cases of lipid regulators,proton pump inhibitors (PPIs), and antidepressants,large prescription volumeswere not reflected in large revenues fortherapeutic classes. The lipid regulatorswere the biggest sellers, earning $18.4billion as a group. They were trailed, inorder, by PPIs ($14.1 billion) and antipsychotics($13.1 billion). PPIs ranked 6th innumber of prescriptions during 2007.3,4
Fewer Blockbusters
Generics accounted for about 20% ofdrug dollars in 2007, and the loss of marketshare for brand name drug manufacturerswas not offset by the market entryof new blockbusters.5 The FDA approveda 5-year low of 18 new drugs in 2007,whereas products such as Ambien (zolpidemtartrate; sanofi-aventis), Norvasc(amlodipine besylate; Novartis), andZyrtec (cetirizine; Pfizer) were exposed togeneric competition for the first time.6,7
A Barron?s survey of FDA publicrecords and industry experts revealedthat the highest expected number ofnew molecular entity approvals for 2008was 29. According to the magazine, only5 of these possible approvals could beexpected to reach $1 billion in annualsales by 2015.8
Antidepressants and AntianemiaDrugs
Sales losses were also likely due todecisions by prescribers and payers toavoid giving and covering drugs to largegroups of patients. IMS and otherresearchers have pointed to 2005 and2007 warnings that antidepressant use ispossibly associated with suicidality asreasons for slow prescription growth and$1.7 billion in lower sales for drugs in thatclass.9,10 Similarly, when evidence that theantianemia injections could potentiallylead to clotting problems and moreaggressive cancers, the FDA requiredstricter warnings for erythropoiesis-stimulatingagents, such as Ortho Biotech?sProcrit (epoetin alfa) and Amgen?sAranesp (darbepoetin alfa). Medicarethen issued new rules last year denyingreimbursement for most uses of theagents.11,12 Overall sales of the erythropoietinsdeclined from $10.1 billion in 2006to $8.6 billion in 2007.
Click on table above for larger image
Click on table above for larger image