Pfizer's blockbuster drug Lipitor goes generic

November 30, 2011 by Veronique Dupont

Pfizer's patent on the best-selling drug of all-time, the cholesterol-lowering medication Lipitor, expired on Wednesday, opening the path to generic competitors for America's most popular medication.

Lipitor came on the market in 1997, and has raked in some $100 billion for Pfizer even in a crowded market that includes various other cholesterol-lowering statins, many of which have already gone generic.

In the United States, anti-cholesterol drugs account for 255 million prescriptions a year, and about nine million people are taking Lipitor.

India's pharmaceutical giant Ranbaxy won US approval to make the first generic version of Lipitor, known as atorvastatin, from its New Jersey lab, after the company had faced delays from US authorities due to problems with quality control at some of of its Indian factories.

US-based Watson Pharmaceuticals also announced a deal to distribute a generic version made by Pfizer, whereby Pfizer manufactures the drug and Watson sells it, sharing net sales with Pfizer until 2016.

"There should be a price war in that first six months," as more companies elbow for market share of the cheaper generic version of Lipitor, said Morningstar analyst Damien Conover.

Meanwhile, Pfizer is left hunting for new sources of revenue to replace the cash flow from its longtime star, which made up 15 percent of annual sales.

Pfizer has not released its projected losses due to the patent expiration, but its company forecasts call for sales in 2012 of $63-63.5 billion, versus $67.8 billion in 2010.

Lipitor global sales were over $10 billion last year, according to earnings reports. Conover estimated a sales figure of $3.8 billion in 2012.

Pfizer already lost exclusive rights on the product in Canada, Spain, Mexico and Brazil last year, but it continues to earn revenue in developing countries.

In the United States, Pfizer is aiming to defend its territory and undercut its competitors in the generic market.

By forming alliances with pharmacies and health insurance companies, Pfizer will continue to offer Lipitor "at or below generic cost" during the next 180 days, company spokesman MacKay Jimeson told AFP in an email.

"In this 180-day period, typically payers do not receive a significant cost-savings by utilizing a generic," he added.

Lipitor currently costs about $120 per month, a price that should drop 30 percent in December, slightly more than the typical 10-20 percent that a drug price typically falls after a patent expires.

Pfizer has made a deal with Diplomat Specialty Pharmacy in the northern state of Michigan to create the program "Lipitor For You," so customers can sign up online to continue to get the drug in their pharmacy or home-delivered.

It is too early to know if this approach will continue beyond six months. Pfizer could decide to continue to compete with other generic makers but it would have to lower prices even more, which may not prove profitable.

Pfizer is counting on licensing deals that will continue to generate revenue from Lipitor, such as one signed with the French pharmaceutical giant Sanofi-Aventis which will make and market its generic version in France starting in May 2012.

"I don't think they'll be able, in the short term, to compensate, but they have a lot of products in pipeline," said Conover, referring to Pfizer.

Among them are an anti-clotting drug known as Eliquis, and another against rheumatoid arthritis known as tofacitinib, which together could make up a billion dollars in annual sales.

Ratings agency Standard and Poor's said it views the New York-based drug giant as well-placed to survive the expiration of the patent on Lipitor.

"Over the next two years, the company will be able to weather the upcoming storm of patent expirations and associated revenue loss while maintaining its excellent business risk profile and a solidly minimal financial risk profile."

A two-year study released earlier this month showed that maximum doses of Lipitor and its competitor Crestor, made by AstraZeneca, were similarly effective and safe in cutting down plaque in the arteries. Side effects may include liver and muscle problems.

With Lipitor now generic, Crestor will be left as the sole major brand-name statin on the market.

"The market for Crestor will go close to zero," said Cam Patterson, chief of cardiology at the University of North Carolina-Chapel Hill.

Explore further: Pfizer maneuvers to protect Lipitor from generics

Related Stories

Pfizer maneuvers to protect Lipitor from generics

November 29, 2011
(AP) -- Lipitor is so valuable that its maker, Pfizer Inc., is practically paying people to keep taking the blockbuster cholesterol medicine after generic competition hits the U.S. market this week.

Americans turn to generic medications in 2010: report

April 22, 2011
(Medical Xpress) -- In a new report released by the IMS Institute for Healthcare Informatics, the results show that over 78% of the almost four billion prescriptions written in the U.S. in 2010 were for generic drugs. The ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

knikiy
not rated yet Nov 30, 2011
Side effects also include amnesia and a whole lot more not mentioned here.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.