With the launch of an authorized generic, Lipitor — the medication that defined the term mega-blockbuster — has now lost patent protection. Astutely managed chain pharmacy organizations have calculated the effect on sales and margins going forward.


Lipitor, mega-blockbuster, patent protection, Robert Coopman, branded generic, generic battle, chain pharmacy, new medications, Food and Drug Administration, Pradaxa, Boehring­er Ingelheim, Eliquis, Pfizer, Bristol-Myers Squibb, Bayer, Xarelto, dalcetrapib, Roche, torcetrapib, AMR101, Amarin, GlaxoSmithKline, Lovaza, Novartis, QVA149, Solanezumab, Eli Lilly, Alzheimer's disease










































































































































































































































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Analysis: What's the next blockbuster after Lipitor?

December 2nd, 2011
An authorized generic version of Pfizer's Lipitor was released by Watson Pharmaceuticals this week.

NEW YORK – With the launch of an authorized generic, Lipitor — the medication that defined the term mega-blockbuster — has now lost patent protection. Astutely managed chain pharmacy organizations have calculated the effect on sales and margins going forward.

Although it will effectively take until late spring of 2012 when branded generic versions of Lipitor lose protection and the real generic battle ensues, one is left to ponder where to go from here. There is reason to be encouraged.

In the past 12 months the Food and Drug Administration approved 35 new medications, the most in one year in the last decade except for 37 approved in 2009.

Two of those medicines are unique. One drug for melanoma and one for lung cancer were each approved with a diagnostic test to help identify patients for whom the medication is likely to be most effective.

And nearly half of the approvals were judged to be significant therapeutic advances over existing therapies. Among them are medications for coronary infarctions, stroke and kidney transplant rejection. Ten are for rare or “orphan” maladies.

When considering when and where new blockbusters might be coming beyond those that have already been approved, there is more reason to be encouraged.

Safer and even more effective replacements for warfarin are projected by some industry analysts to be a $20 billion market in the not-too-distant future.

When considering when and where new blockbusters might be coming beyond those that have already been approved, there is more reason to be encouraged.

In this segment Pradaxa from Boehring­er Ingelheim is first to market and is getting significant traction. The outstanding question for Pradaxa sales is how high is up, a query that will be impacted by new competitors from Bayer and Pfizer.

Collaboration from Pfizer and Bristol-Myers Squibb will be in the game. It is apixaban, brand name Eliquis, and has shown dramatic results in a major Phase III trial.

While performing significantly better than warfarin, Eliquis also reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and mortality by 11%. Analysts are calling it a mega-blockbuster contender.

Bayer will also be in the game. Its rivaroxaban, whose brand name is Xarelto, has already been approved for preventing blood clots after orthopedic surgery. More importantly, Bayer has a marketing approval application pending with the FDA to prevent strokes. That is where the real sales potential lies.

In the cardiovascular arena, dalcetrapib from Roche is an agent that has shown outstanding results to increase levels of HDL cholesterol. What’s more, 476 patents in a study were shown to have none of the cardiovascular risk that scuttled Pfizer’s torcetrapib. Sales potential is projected at $5 billion to $10 billion.

Some analytical work from Kaiser Permanente would seem to support such a sales potential. Kaiser has analyzed data from 30,000 patients with type 2 diabetes and found that moderate improvements in HDL have a significant positive effect on the patient’s risk for heart disease and stroke.

In the triglyceride arena, AMR101 from Amarin — a prescription-grade omega-3 drug that reduces triglyceride levels — is expected to have a sales potential of $3 billion. AMR101 also has been shown to lower LDL.

If and when approved by the FDA, an event that is projected for 2012, it will compete with GlaxoSmithKline’s Lovaza.

Chronic obstructive pulmonary disease patients with “smokers cough” may soon have a helpful medication from Novartis. Its QVA149 is said to be positioned to change the standard of care for smokers cough and will compete with Advair and Spiriva. Analysts have projected sales of $2 billion to $5 billion.

Alzheimer’s disease presents another case for encouragement. The segment is projected to be worth some $14 billion to $15 billion by 2020 in the United States, Germany, France, Spain, the United Kingdom, Italy and Japan.

Solanezumab from Eli Lilly is projected to slow disease progression and memory loss. A caution about Alzheimer’s is that there remains so much to be learned about the disease and its potential treatments.

Some among us hope that learning ramps up quickly.

Editor's Note: Robert Coopman is the president of Robert Coopman Consultants, which is based in San Antonio. He can be contacted via e-mail at rcoopman67@gmail.com.

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