5 Bestselling Drugs and Medications in 2011

Americans spent $320 billion on prescription medications in 2011, no paltry sum. A number of big blockbuster medications lost patent and went to cheaper generics, which might explain why spending was flat since 2010.

The major profits made by medications in the past year cluster around a group of 5 medications that were far and away the biggest money-makers of 2011.

#5  - The 'asthma king'

Made by London-based GlaxoSmithKline (GSK), Advair Diskus, launched in the US in 1998, is used for prevention and treatment of asthma and chronic lung diseases.

When GSK launched Advair Diskus in the U.S. in 2001, they felt certain it would be a significant money-maker for them, both since the Food and Drug Administration granted them broad usage (in all asthma patients over 12; later it would be approved for COPD), and since the U.S. offers access to the single largest market for asthma drugs.

The Diskus was new technology at the time, allowing delivery of precise individual doses of the drug, an improvement over non-diskus inhalers through which it was difficult to know how much of the medication was actually being delivered to the system.

So the promotional action began, emphasizing Advair's easy-to-use formulation. The inhaler's insert wrote that Advair, at the time, was the first and only medication in America that let people "effectively treat the two main components of asthma, inflammation and bronchoconstriction, with one easy-to-use device."

GSK's "Half-Year In Review 2001" touts the success of Advair--and their own marketing approach:

"The biggest product news of our first six months was the highly successful US launch of Advair for asthma. In the first few months since its launch in April, Advair has already surpassed the half million retail prescription mark--and had also moved beyond the $100,000,000 mark."

The Review goes on to proudly state how GSK achieved such success. Asserting that they sent 2300 sales reps to contact 70,000 physician prescribers in the first five days of the marketing launch alone, GSK was pleased enough with initial success to assert that "Advair . . . appears to be on its way to becoming the gold standard in asthma treatment."

And success continued to find GSK.

By 2006 some referred to the company as the "Asthma King."  Sales for the Advair franchise rose 12 percent in first quarter, to $1.5 billion, following a 22 percent rise in 2005, to $5.6 billion, with projections that sales (across the globe) would reach $6.9 billion in 2006, and, potentially $9.1 billion in 2010.

But projections don't mean everything, and optimism only carries you so far. In fact, by 2009 sales had dropped to $4.7 billion, as competing inhaler medications gained ground.

Advair Diskus lost patent protection in the U.S. in 2010. However, various patents over the special Diskus delivery device still hold in the U.S. up to 2016, and ones for the DHFA device exist until 2025.

Additionally, to GSK's great advantage, generic forms were delayed due to some foot-dragging by the Food and Drug Administration when it came to deciding a standard for equivalent dry powder inhalers.

Given the patent on dispensing technology and the FDA concerns about equivalency, there were distinct challenges that delayed the initial run of a generic as soon as Advair lost patent, buying GSK time and money.

Their continued hold on the market is indicated by their sales in 2011-- an extremely respectable $4.7 billion, the fifth best-selling drug in the U.S.

Anyone can breathe easy with numbers like that (and a patent stranglehold on delivery).

#4 - The 'third generation' antipsychotic

Abilify, an antipsychotic medication first approved to treat the delusions and hallucinations of schizophrenia in 2002, was born at a good time to be an antipsychotic.

In the past fifteen years, prescriptions for antipsychotics have doubled.

Lucky for Bristol-Myers Squibb, who jointly markets Abilfy in the U.S. with Otsuka America Pharmaceutical.

There are 6 newer antipsychotics, called 'second generation antipsychotics' because they work differently than older antipsychotic drugs, and Abilify was the last to arrive on this new scene. Surely it didn’t bode well.

But, Abilify doesn't have some of the particularly egregious side effects of its antipsychotic cousins like Zyprexa--the metabolic syndrome, weight gain, and diabetes.

In fact, there are also some complex chemical distinctions between Abilify and the others, leading some scientists to call the drug, still keeping in mind its different side effect profile, a 'third generation antipsychotic,' moving beyond the other 'second generation' ones. .

After its approval for schizophrenia, Abilify was also officially approved to treat: bipolar disorder, as a maintenance drug, acute manic or mixed episodes of bipolar disorder, irritability associated with autistm, and as an add-on to an antidepressant to treat major depressive disorder--the first second generation antipsychotic to win such approval. With all these indications, Abilify has become Bristol-Myers' second best earner--behind a drug we'll see in spot #2.

Abilify took advantage of its versatility. As a feather in Bristol-Myers' cap, they were the only company granted the legal right to market to people without schizophrenia or bipolar disorder. That, as Frost might have said, has made all the difference.

Its promotional spending has consistently been off the charts. In 2006, for example, Bristol-Myers spent $329 million to promote Abilify, while the second largest spenders, makers of Zyprexa, spent only $184 million in marketing.

The reps made themselves known in psychiatrists' offices, sent out countless samples, advertised in medical journals, and put out ad after ad.

The PR blitz only grew with each new approval. In 2007, with its drug now approved for treating bipolar disorder, Abilify-makers blanketed neighborhoods of cities with young people, more likely to be recently diagnosed with bipolar, taping thousands of posters to the sides of public phone booths. This successfully moved it from last on the totem poll in second generation antipsychotics to third most prescribed.

Although actually antipsychotic Seroquel had more prescriptions written for it than Abilify in 2011, Abilify's staggering cost helps keep it in the Top-5 Grossing Medications List.  A month's supply of Abilify, without insurance, is easily over $900.00; in 2011 it earned its companies $5.2 billion.

#3 - The purple pill

Drug maker AstraZenaca was already making a killing with its drug Prilosec (omeprazole) for acid reflux ("heartburn" to those of a certain age).

But all good things must end, and AstraZeneca was set to lose patent protection on Prilosec in 2001, meaning lower-priced generic versions could enter the market.

Something had to be done to keep up profits--and timing is everything. Just as the patent was about to expire, AstraZeneca received FDA approval for Nexium, and went on a PR blitz hard to rival. With a $500 million ad campaign declaring "Today's purple pill is Nexium, from the makers of Prilosec," AstraZenaca added 1300 sales representatives to promote the drug to doctors.

Apparently not everyone was enthralled with AstraZeneca's approach.  The company was sued multiple times in 2004 and 2005 for unlawful and deceptive marketing practices and for unfair pricing of the drug. Conveniently, as well, soon after its patent, there was a sudden shortage of the OTC Prilosec, and patients were forced to turn to the more expensive Nexium, a 'happening' for which AstraZeneca was taken to task.

Most of the cases have been dismissed.

Although a number of scientists argued that there was very little difference between the now-over-the-counter Prilosec and the pricy patented Nexium, the campaign clearly sold doctors on the pill, which, by 2003 had netted a staggering $3.1 billion. By 2008, Nexium was the third-largest selling drug world-wide, with annual sales of $5.2 billion, up to $7.9 billion in 2011.

No one should cry for 'the purple pill,' but Nexium's excellent run is expected to collapse in 2014 when it loses patent, and Teva Pharmacueticals markets its generic.

As big of a blockbuster as Nexium became—and it’s cearly a big one--its total prescriptions never even reached half the number of those of the #1 all-time best-selling medication.

#2 - The research study that sold the FDA--and the world

France-based Sanofi-Aventis Pharmaceuticals discovered Plavix and worked to co-develop it with larger drug-maker Bristol-Myers Squibb since 1993. Each developed one compound of the two-compound drug, and thus the medication was manufactured and distributed world-wide by both companies.

Plavix is a blood thinning medication prescribed to prevent heart attack and strokes.

Its future was really made by one major study, published in The Lancet in 1996, entitled "A randomised, blinded, trial of clopidogrel [Plavix] versus aspirin in patients at risk of ischaemic events (CAPRIE)." Studying 19,185 patients, the authors concluded that long-term administration of Plavix to patients with heart disease was more effective than aspirin in reducing the risk of stroke or heart attack--and its safety profile was at least as good. That paper remains astoundingly well-known and referred to, with 2238 citations in the medical literature as of April 2012.

That was all the medical and consumer public had to hear--not to mention the Federal Drug Administration, which granted a patent in response to the findings. And hear they did, as Bristol-Myers launched a major advertising campaign in 2001, spending $350 million in ads aimed at consumers to promote the use of their drug, yielding sales of $5.9 billion by 2005. Of course, sales weren't hurt by the price hike Bristol-Myers instituted either: the price of Plavix was increased 12%, or 40 cents a pill, just when the campaign began.

The advertising campaign was highly successful among consumers. At the end of 2005, according to IAG Research, a TV effectiveness ratings company, Sanofi-Aventis' 60-second spot for Plavix was voted the most motivating and encouraged the highest level of  "stated intent to take action" among those 18 and older. [It would only be followed in this category by a 45-second spot for a pill to treat reflux/heartburn—return to #3.]

Plavix was a major departure from other drugs previously used to treat heart conditions in that it was the first demonstrated in a number of patients to reduce the risk of heart attack and death when used in combination with aspirin therapy. Physicians understood its potential--and prescribed accordingly.

Through its run, Plavix was a cash cow for Bristol-Myers-- the company's leading product. During its 15 years on the market, it eventually made up almost half of Bristol-Myers' U.S. sales, pulling in an estimated $42.8 billion.

In 2010, Bristol-Myers earned $6.7 billion in Plavix sales, representing 49 percent of US net sales.  Sanofi made out well, too. They earned around $2.7 billion, the equivalent of 7% of its 2010 earnings.

All giants must fall. In May, 2012, Bristol-Myers lost patent, and the company immediately pulled back from aggressively marketing the drug. Estimates are that Plavix sales will decline by 60% in the upcoming year, and as a sign of the decline, by 2011 they were already down to $6.2 billion.

Still, having been the second-highest grossing medication in the U.S., behind a blockbuster like no other, is no mean accomplishment for a small pink tablet.

#1 - The best-selling drug in the history of the world

Pfizer, the world's largest drug-maker, has done well, financially speaking. Year after year it's had no small amount of money coming in. But Lipitor has accounted for 20 percent to 25 percent of Pfizer’s annual revenue for years.

Invented by one Bruce Roth in 1985 (for which he won multiple awards, including 2008 Hero of Chemistry by the American Chemical Society), the drug has gone on to become the single best-selling medication in history.

It was a latecomer in the field of statins, drugs that lower LDL or bad cholesterol, following blockbusters Zocor (simvastatin) and Pravachol.

In fact, Lipitor almost never saw the light of day. But as Jie Jack Lie writes in his book Triumph of the Heart: The Story of Statins, just as management was preparing to stop further development of the drug because they believed it could never complete, the head biologist for the program got down and one knee, and, to the tune of Al Jolson's "You Made Me Love You, sang out:

"You've got to let us do the human tests. I know it's the right thing to do, and I'm begging you to do it."

Apparently management was pretty impressed--and didn't have a lot of other drugs to rush to market in Lipitor's place either.

Development continued apace.

Then sometimes drugs get lucky. Lipitor didn't go on sale until 1997, but that just happened to be the year the Food and Drug Administration first allowed drug ads aimed at consumers.

So Pfizer went on a marketing campaign to the tune of millions of dollars, blanketing the airwaves, (remember the "Know Your Numbers" commercials?), supplying free samples to internists as well as cardiologists, and promoting their data, which indicated Lipitor was even more effective than the other statins, to just about anyone who would listen.

It was a great success--in fact, there's never been one quite like it. In 2011 alone it earned Pfizer $12.5 billion.

Its patent expired on 11-30-11.

It has had the run of a lifetime.

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This was a guest contribution by Rhona Finkel.  Rhona is a health and science writer, covering such topics as mood disorders, technology and health, the plight of the mentally ill, psychiatric medications, and updates and retractions in scientific literature. Also a consultant in social media publicity, she is an author on Candida Abrahamson’s blog at http://candidaabrahamson.wordpress.com.