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  The Side Effects of Going Off Patent   The Side Effects of Going Off Patent  Edwin Colyer  
         
 
The Side Effects of Going Off Patent Remember Prozac? Not long ago it was one of those pharmaceutical superheroes -- glittering revenues over many years, high patient acceptance, and a name known around the globe. Those heady days of fame and fortune are gone for good. In 2001, the drug lost its US patent protection. Generic fluoxetine flooded the market and Prozac sales plummeted by about 80 percent. The name lives on, but is this all that good marketing can achieve -- 10 short years of maximum sales before a terrible fall?

"It's the old bugaboo of patent expiry," comments David Wood, CEO of Interbrand Wood Healthcare. " 'Gee, what am I going to do when I lose the patent?' people ask. Today it's the same old monster except bigger -- the brands are bigger and therefore they have more to lose.

"The attitude is still 'Let's make the most out of this product, then walk away.' " Wood claims. He believes that companies (understandably) try to maximize sales during the brand’s protected life. Marketing executives have warmed to the idea of branding, but still more or less abandon products a few years later once generic competition arrives. "When patents expire, most often companies do nothing or fight competitors in the courts rather than the marketplace," he says.

Brand equity is precious; it now seems to be an integral part of company valuations. Is the pharmaceutical industry foolhardy in its fickle attitude to its burgeoning brands? Surely they can live beyond their patent life, not just in name but in the bottom line too.

Squeezing extra value from drugs as they near the end of their protected life is far from easy, although companies have numerous possible tactics. Reformulation is perhaps the most common. A relatively small investment (compared to developing a completely new drug) could buy a technology that offers a new lease on life to the drug as an "enhanced" version: longer lasting, stronger action, easier dosing.

Many products have gone this way, incorporating controlled release or other drug-delivery technologies: Procardia became Procardia XL, Prozac became Prozac Weekly. Strong branding paves the way as people happily switch to a more effective version of the product.

 
Reformulation offers great opportunity for drug delivery specialists to piggyback on the branding too. "When Biovail bought the Cardizem brand from Aventis, it had around US$ 250 million in sales. Aventis didn't attach much value to it. Yet for 10 years the sales force had so established the brand that no one called it by its generic name," says Brian Morrissey from the Frankel Group, a pharmaceutical consulting firm . "Biovail made a controlled release version of the product and called it Cardizem XL so it could no longer be substituted for a generic. They didn't need to go out and sell Cardizem, just the ‘XL.’” The brand value, created by Aventis, is now captured by Biovail.

Sometimes companies choose to seek new indications for their drugs. The FDA approved Eli Lilly's Prozac, for instance, for the treatment of premenstrual dysphoric disorder in women. However, the approval of new indications creates as many problems for marketers as it generates more sales. First, the FDA insists that products for new indications must have a new name. Thus Prozac became Sarafem and GlaxoSmithKline's antidepressant Wellbutrin is called Zyban in its alternative indication as a smoking cessation drug. In short, while new indication approvals help sales, the established brand equity has little role to play.

David Wood argues for more creative thinking, and points to consumer goods for inspiration. "The delivery vehicle for products is something that the industry needs to get better at. In the US you get drugs in amber vials given by the pharmacist. That's like Coca-Cola delivering in bulk and the retailer putting it in whatever bottles they like. Using packaging as part of the branding makes it harder for generic companies to copy."

But a simple fact remains: Pharmaceuticals are not consumer goods. And the consumer does not pay for drugs directly. Moreover, beyond patent expiry, drugs compete on price alone. Pharmacists can substitute cheaper generic products for name brands on a patient's script (unless otherwise stipulated by the prescribing doctor).

 
Yet even if the product dies, the brand still lives. "It is not possible to roll the brand over to a new product unless it is a reformulation, but you can keep certain elements of previous brands," says Oliver Sexton, an analyst with Datamonitor. He cites AstraZeneca as an example. Heartburn medication Prilosec -- "the purple pill" -- lost its main patent in 2001. Next-generation Nexium had a hard act to follow. But AstraZeneca took one of Losec's most distinctive features and gave Nexium a useful shorthand: it looks like Losec, and probably does just as good a job. The color lives on and announces that "The purple pill is back. Nexium is Losec Mk.2!"

"Similarly Schering-Plough didn't want to gamble on an entirely new brand. It would be kind of foolish to lose all that brand awareness," says Sexton. "Clarinex is a new brand but with similarities to Claritin.

"The problem with this is that companies may have spent 10 years convincing people that their first branded product is best, then they have to somehow get people to switch," explains Sexton.

But Schering-Plough has fallen foul of its own success. Claritin is a major consumer brand, now successfully competing with other over-the-counter (OTC) products since the US Federal Drug Administration approved its OTC status in November 2002. Why try Clarinex, the consumer must ask, when Claritin is right there in my local drug store?

"It's always a benefit of strong brands that you might be able to carry over to OTC, where it becomes more like FMCG branding," notes Sexton. "Branding with OTC may then help to have a higher price point."

"Ideally the years of building brand equity as a prescription product should be designed to make it easy to go into OTC world," adds Wood. "Today with direct-to-consumer advertising, we have a virtual OTC market. There are lots of opportunities to practice and have expertise in developing brands which appeal to the non-professional audience."

Yet despite the growing use of consumer advertising, Wood remains skeptical about the power of most pharmaceutical brands to hold out beyond patent expiry. "Frankly I don't think the industry is good yet at creating powerful brands. It's good at creating products with massive sales. These massive multinationals should be able to generate huge brands, but when blockbuster products lose protection the brand usually goes with them. People don't walk away from Coca-Cola or Shell gasoline quite so readily, so pharma obviously hasn't got there yet."    

[24-Mar-2003]

 
  
  

Edwin Colyer is a science and technology writer based in Manchester, UK.

     
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