Practical Defense Strategies for Combating Generics Competition

Introduction Can branded pharmaceutical companies ever win the war against generics? No. But they can win some of the battles. Growing pressures on innovator companies means that innovator companies are becoming more inventive in searching for blockbuster products-which in turn increases the pressure on generics companies to find ways of bypassing new defense barriers. Now, innovator companies can choose from among a variety of specifi c, practical tactics to defend themselves from the threat of generics-either by defending the company as a whole or by defending key individual products that come under attack. Questions Answered in This Spectrum Report: In May, 2007, after previously enjoying success from its diversifi cation into generics, Merck KGaA sold its . generics business to Mylan for $6.6 billion. What strategy is Merck KGaA now taking to help avoid the threat of generics and help defi ne its future? Medco Health Solutions, a pharmacy benefi ts manager, has been looking forward to the 2007 expiries of . patents on ten major branded drugs. Which of these drugs has Medco singled out as providing huge savings after patent expiry? Biological products present several barriers to companies wishing to manufacture imitations. Thus, an . increased focus on biologics-such as vaccines, protein products, and hormones-can help a branded company move its product assortment out of the range of generics companies. Which companies have already switched their R&D focus to biologics? What barriers must generics companies overcome if they wish to play the biologics game. Which generics players are most likely to overcome these barriers? Originator companies have embraced the use of authorized generics; however, in early 2007, the FTC . recommended legislative changes after examining the issue of authorized generics. What lies ahead for this popular tool? Innovator companies are more risk averse than they used to be; the latest trend has been for companies . to contract out some of their R&D risk by cooperating with other R&D specialists-including generics companies. Which R&D company is at the top of the list of generics companies tapped by Big Pharma for their R&D capabilities? Scope Importance of defense strategies: . the slowing pace of NCE introductions; generics penetration in the United States, Europe, and Japan; lessons from the loss of patents to Pfi zer's Norvasc and AstraZeneca's Prilosec; patent expiries due in 2007 on ten major brands. Company-based defense strategies: . mergers, increased emphasis on biologics R&D, contract research, and acquisitions of generics companies. Product-specifi c defense strategies: . adding patents to existing products; developing new isomers and enantiomers of existing products; introducing new versions, formulations, and combinations of existing products; adding new indications for existing products; switching products from prescription basis to OTC; pursuing litigation; launching or supplying authorized generics. Outlook: . threats to authorized generics; cooperation between innovator companies and generics companies; the swing to biological research. Please note, the PDF e-mail from publisher version of this report is for a global site license.

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Drugs Mentioned in This Spectrum Report

Adalat
Advair
Ambien CR
Ambien/Stilnox/Myslee
Avandia
Azilect/Agilect
Baycol
Betaferon/Betaseron
Caduet
Canesten
Celexa/Cipramil
Cipro/Ciprobay
Claritin/Neoclarityn
Co-diovan
Copaxone
Coreg/Kredex
Dimetane
Diovan
Duragesic
Epilim Chronosphere MR
Exforge
Flixotide
Flonase
Glucophage XR
Glucotrol XL
Imitrex
Lexapro/Cipralex
Lipitor
Loratadine
Losec
Minoxidil
Nexium
Norvasc
Omeprazole
Oxandrin
Plavix
Prevnar
Prilosec
Prilosec/Losec
Proscar
Pulmicort
Reminyl XL
Risperdal
Ritalin LA
Seloken ZOK/Toprol XL
Seretide
Serevent
Toprol-XL
Xenical
Xyzal
Zantac
Zithromax
Zocor
Zoloft
Zyrtec/Zirtec
Zytec/Reactine