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JOURNAL OF GENERIC MEDICINES.
VOL. 4, NO. 1. 73–78. OCTOBER 200675
Patent Expiry and Impact Predictors
Zocor since 2005 in preparation for Zocor ’spatent expiry.
SWITCHING SCENARIOS FOR ZOCOR; GENERIC IMPACT ISLIKELY TO BE HUGE
Two key factors will have an impact on futureZocor sales — the level of switching fromZocor to generic simvastatin, and the pricedifference offered by the generic alternatives.Given the following set of assumptions,Datamonitor has estimated sales forecasts for Zocor:US sales of Zocor were US$4.2bn in 2005(Midas Sales Data, IMS Health, March2006);three generics will be launched within theﬁrst six months of patent expiry — Teva’sand Ranbaxy’s ﬁrst-to-ﬁle, and Dr Reddy’s
authorised generics;around eight additional generics willbe launched after the expiration of the
180-day exclusivity period, with a further 10 – 15 being launched by the end of theforecast period.Despite Merck & Co.’s attempts to limit theimpact of generics on Zocor revenues byinking a deal with US health insurer UnitedHealth Group whereby branded Zocor wouldbe less expensive than the generic versions, itis still expected that other healthcare providerswill continue to push for maximum switchingto generic simvastatin. In line withpreliminary switching data,
Datamonitor expects that in the ﬁrst six months followingpatent expiry, a high (75 – 80 per cent) level of switching from Zocor to generic simvastatinwill take place, the impact of which isillustrated in Figure 1 along with low (20 per cent) and medium (50 per cent) switchingscenarios.While there are a number of measuresbeing employed in the US to encourageswitching from branded drugs to cheaper
The US statin monotherapy* market, 2005
Brand Generics MarketingcompanySUs 2005 (m) Growth2004 – 05 (%)Sales 2005(US$m)Growth2004 – 05 (%)Lipitor Atorvastatin Pﬁzer 3,200 2.7 8,064 8.5Zocor Simvastatin Merck & Co. 1,566 (7.7) 4,206 (4.7)Pravachol Pravastatin BMS 500 (19.9) 1,655 (13.9)Crestor Rosuvastatin AstraZeneca 345 23.8 797 36.3Lescol Fluvastatin Novartis 184 (12.6) 336 (8.3)Mevacor Lovastatin Merck & Co. 3 39.3) 8 (36.4)Total 5,798 (2.3) 15,066 2.3Does not include sales of combination therapies (eg Vytorin, Caduet)BMS – Bristol Myers SquibbSource: IMS MIDAS sales data, IMS Health, March 2006
Patent position for each of the statins in the US
Brand Generic Marketing company Expiry date US patent numberMevacor Lovastatin Merck & Co. Jun 2001 US04231938Pravachol Pravastatin BMS Apr 2006 US04346227Zocor Simvastatin Merck & Co. Jun 2006 US04444784Lipitor Atorvastatin Pﬁzer Jun 2011 US05273995Lescol Fluvastatin Novartis Apr 2012 US05354772Crestor Rosuvastatin AstraZeneca Jun 2012 US05260440Source: Dolphin, accessed July 2006,
Thomson Scientiﬁc; FDA Orange Book, accessed July 2006; MedTRACK, July 2006,