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Patent expiry

Patent expiry

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Patent ExpiryImpact Predictor 
Compiled and written by Datamonitor plc
Datamonitor plc (DTML) is a premium business information company specialising inindustry analysis and providing clients with unbiased expert analysis and in-depthforecasts for six industry sectors:
AutomotiveConsumer marketsEnergyFinancial servicesHealthcareTechnologyNo part of this section may be reproduced, stored in a retrieval system or transmitted in any form byany means, electronic, mechanical, photocopying, recording or otherwise, without the prior permissionof the author, Datamonitor plc. The facts of this report are believed to be correct at the time of publication but cannot be guaranteed. Please note that the findings, conclusions and recommendationsthat Datamonitor delivers are based on information gathered in good faith from both primary andsecondary sources, whose accuracy we are not always in a position to guarantee. As such, Datamonitorcan accept no liability whatever, for actions taken based on any information that may subsequently proveto be incorrect. Please contact: Joanna ChertkowDatamonitor plcCharles House108–110 Finchley RoadLondonNW3 5JJUKDatamonitor maintains its headquarters in London and has regional offices in New York, Frankfurt andHong Kong.
 
 © 2006 PALGRAVE MACMILLAN LTD 1741-1343 $30.00
 JOURNAL OF GENERIC MEDICINES.
VOL. 4, NO. 1. 73–78. OCTOBER 200674
www.palgrave-journals.com/jgm
 OVERVIEW OF THE USSTATIN MARKET
Sales of branded statin monotherapies in theUS at the end of 2005 reached US$15.1bn,or 78 per cent of the entire USantidyslipidaemics market, up 2.3 per cent on2004 sales (source: MIDAS sales; IMS Health,March 2006). Key drivers of this commercialsuccess included aggressive, multi-channelmarketing by big pharma, in the shape of Pfizer and Merck, and an overwhelming bodyof data derived from clinical trials that showsaggressive reductions of elevated cholesterol,particularly low-density lipoprotein-cholesterol(LDL-C), with statins reduces the risk of cardiovascular outcomes.
1 – 4
At the productlevel, it was Pfizer s Lipitor (atorvastatin) thatdominated the market with sales of US$8.1bn,or 54 per cent market share, followed byMerck & Co.s Zocor (simvastatin) and four other branded products, as illustrated in Table 1.Of the six branded statins that are currentlymarketed in the US, only one was exposed togeneric competition at the beginning of 2006;Merck & Co.s Mevacor (lovastatin). Mevacor s US patent — US04231938 — expired in June 2001. While sales of Mevacor fell as aresult of generic competition, sales of all other branded statins have been relatively unaffectedby the availability of generic lovastatin. Thekey element of this lack of generic erosioncentres on the perception that lovastatin is notas effective as other statins in reducing LDL-C and cardiovascular events, such as heartattacks and strokes.
IMPACT OF ZOCOR ANDPRAVACHOL LOSING PATENTPROTECTION IN THE US
Since the beginning of 2006, Merck & Co.sZocor (simvastatin) and Bristol MyersSquibbs Pravachol (pravastatin) have lostpatent protection, with the next high-profileloss expected in 2011 when Pfizer s Lipitor (atorvastatin) succumbs to genericcompetition (Table 2). As Pravachol onlyaccounts for around 10 per cent of thebranded statin market, generic pravastatin isnot expected to have a huge impact onbranded statin sales. As for lovastatin, reasonsfor this include physician preference for more potent statins supported by outcomedata.In contrast, many believe that simvastatin isas potent and effective as atorvastatin, a claimthat Pfizer has rigorously disputed in theweeks running up to Zocor s patent expiry,and as such it is the loss of patent protectionfor Zocor that is expected to have asignificant impact on the branded statinmonotherapy market in the US. It has beenestimated that if Medicare beneficiaries wereprescribed low-cost generic statins instead of higher-priced brands, around US$2,300 andUS$5,000 per year could be saved per patient,with some estimating that in excess of US$8bn could be saved in 2007 alone.
5
Onthis basis, many Pharmacy Benefit Managers(PBMs) and Managed Care Organizations(MCOs) in the US have been switchingpatients from other branded statins to
Patent expiries in the US statinmarket: Generics to slash market sizeby 80 per cent over the next ten years
Duncan Emerton
is a senior analyst in Datamonitors Cardiovascular team.
 Journal of generic medicines
(2006)
4,
73 – 78. doi:10.1057/palgrave.jgm.4950048
 
 © 2006 PALGRAVE MACMILLAN LTD 1741-1343 $30.00
 JOURNAL OF GENERIC MEDICINES.
VOL. 4, NO. 1. 7378. 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$4.2bn in 2005(Midas Sales Data, IMS Health, March2006);three generics will be launched within thefirst six months of patent expiry — Tevasand Ranbaxys first-to-file, and Dr Reddys authorised generics;around eight additional generics willbe launched after the expiration of the
180-day exclusivity period, with a further 10 – 15 being launched by the end of theforecast period.Despite Merck & Co.s attempts to limit theimpact of generics on Zocor revenues byinking a deal with US health insurer UnitedHealth Group whereby branded Zocor wouldbe less expensive than the generic versions, itis still expected that other healthcare providerswill continue to push for maximum switchingto generic simvastatin. In line withpreliminary switching data,
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Datamonitor expects that in the first six months followingpatent expiry, a high (75 – 80 per cent) level of switching from Zocor to generic simvastatinwill take place, the impact of which isillustrated in Figure 1 along with low (20 per cent) and medium (50 per cent) switchingscenarios.While there are a number of measuresbeing employed in the US to encourageswitching from branded drugs to cheaper 
Table 1:
The US statin monotherapy* market, 2005
Brand Generics MarketingcompanySUs 2005 (m) Growth2004 – 05 (%)Sales 2005(US$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
Table 2:
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,
©
Datamonitor plc

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