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Readers of this blog know that we here at PAL are no fans of Nexium, AstraZeneca’s [NYSE:AZN] blockbuster drug for erosive esophagitis, heartburn and Gastroesophageal Reflux Disease (GERD). Nexium, a so-called “proton pump inhibitor,” is the successor to Prilosec, and is essentially no better than Prilosec. Nexium is the brand name for the chemical known as esomeprazole. It is the “S-enantiomer,” or chemical mirror of Prilosec, or omeprazole. The main difference is that Nexium has three yellow stripes. But it’s more than 8 times more expensive than Prilosec, which is now available Over-the-Counter. (Today, the price on drugstore.com for 30 tablets of Nexium 20 mg was $164.31, and a box of 42 tablets of Prilosec was $26.99 – that’s $5.47 per pill for Nexium, compared to 64 cents a pill for Prilosec, meaning you could get 8.54 Prilosec pills for the same price as one Nexium.)
The bottom line is that millions of people take Nexium, and pay dearly for the privilege, when they would do just as well with a cheaper generic Proton Pump Inhibitor, over-the-counter Prilosec, or another over-the-counter heartburn medication like Pepcid, Zantac or plain ol’ Tums. And why do they take Nexium? Overwhelmingly because of the aggressive marketing that Astra Zeneca pours into it, directed at both consumers (TV ads, magazine ads for “The healing purple pill”) and physicians (through pharmaceutical salespeople).
So we regard last week’s news that Ranbaxy Laboratories got tentative approval from the FDA to market generic Nexium (esomeprazole) with some amazement. Does the world need a generic version of Nexium? If it’s the same as Prilosec, isn’t it unnecessary? Aren’t the seemingly innumerable numbers of heartburn drugs on the market enough, particularly since they don’t differ all that much in terms of how effective they are?
The answer is, that’s beside the point. A generic will be introduced because the market for Nexium is huge — $5.2 billion in annual global sales, according to a Reuters article. If and when generic Nexium comes on the market, there are millions of people with prescriptions for Nexium who will have that prescription automatically substituted with a generic, saving them money, and giving them exactly the same level of relief. So isn’t that a good thing?
Perhaps. Generics are terrific. Consumers should use generics more than they already do. The obstacles that brand-name drug companies put in the way of generics coming to market (frivolous patent lawsuits, frivolous FDA petitions, authorized generics, reverse payment settlements, etc.) should be prohibited. Generic drug companies should challenge bogus patents. While that’s all true, a generic version of a drug that the world never needed in the first place feels like a hollow victory. I’d rather see the pharmaceutical industry focus on genuinely innovative treatments that don’t just duplicate — often exactly — treatments that already exist, or yet another “extended relief”/once a day/once a month version that’s just aimed at preserving market share. Then I’d like to see generic versions of those truly breakthrough treatments become available as soon as valid patents on them expire, without unnecessary interference by the brand-name holder of the patent.
My worries of course are probably premature. The FDA only granted tentative approval, not final approval. Astra Zeneca has no intention of letting its cash cow go without a fight. If and when the FDA grants final approval, you can be sure that Astra Zeneca will sue Ranbaxy for patent infringement before the final approval letter is even out of the envelope. As AZ’s CEO said recently:
“Our position has been we have strong intellectual property and we intend to defend it and stand behind it. Obviously, we have options available to us. We always explore options that are available but it’s clear to us that we have an intellectual property argument to make and we are making it.”
So, dear Readers, what do you think? Does the world need a generic Nexium? Post your thoughts in the comments.
We’ve been harping on Nexium for several years now. AstraZeneca’s (NYSE:AZN) supposed “healing purple pill” is nothing more than a dressed-up version of its previous blockbuster gastric reflux drug, Prilosec. We gave Nexium a Bitter Pill Award in 2005, the The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag. Our members have been involved in several class action lawsuits alleging the Astra Zeneca deceptively marketed Nexium as an improvement over Prilosec, when in fact it is clinically no different. (As we’re fond of saying, the only difference between Nexium and Prilosec is that Nexium has yellow stripes and costs seven times as much).
We’ve always marveled at why Nexium is as successful as it is when Prilosec is available Over-the-Counter at a fraction of the price. The answer, of course is simple: Marketing. As we’ve written (see, for example “Top 3 Bestselling Drugs spent $460.5 Million on Ads in 2006″), Nexium owes its $4.3 billion in 2006 annual sales to the $176 million that Astra Zeneca spent that year on ads like this:
Now there’s even less of a reason for people to use Nexium instead of cheaper alternatives, including Over-the-Counter Prilosec. FDANews.com reports that Dexcel Pharma Technologies will soon begin selling a generic version of Over-the-Counter (OTC) Prilosec. Astra Zeneca sued Dexcel to prevent it from selling generic OTC Prilosec, but has settled that lawsuit with Dexcel.
Most people think of generics when they think about prescription drugs, not Over-the-Counter ones. But drug companies frequently get FDA permission to stop generic competitors for 3 years when a drug first becomes available over-the-counter. This is why up til now, you haven’t seen, for instance CVS or Walgreen store brand Prilosec.
Dexcel says that OTC Prilosec should be available by the end of March 2008. The competition between Astra Zeneca’s Prilosec and Dexcel’s generic version should drive the price down. This is yet another reason consumers don’t need to pay through the nose for prescription-only Nexium.
But even before you reach for that cheaper box of OTC Prilosec, you should consider whether even less expensive alternatives will do the trick — such as Tums, Zantac, Pepcid, and other over-the-counter heartburn drugs. Consumer Reports Best Buy Drugs has a report on heartburn medicines, and it says, in part:
If you suffer from only occasional heartburn and have not been diagnosed with GERD [gastric reflux disease], nonprescription antacids such as Maalox, Mylanta, Rolaids, and Tums, or acid–reducing drugs such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) will very likely provide relief.
Talk with your doctor about the role that dietary and lifestyle changes can play in alleviating heartburn, too – such as eating smaller meals, weight loss, and avoiding alcohol.
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