Pfizer's Lipitor Causing Major Shifts in the Market

The first generic Lipitor (atorvastatin) is hitting the pharmacy shelves as this blog entry is being written.  When most drugs go off-patent and receive their first generic competition the impact is relatively minor. 

Lipitor has been the #1 selling prescription drug in the world with sales exceeding $10B in 2010, and $11B in 2009 - so it is very big news. (Click to download the Pfizer 2010 Annual Report)

Humanity will be the biggest beneficiary as the average selling price for atorvastatin will drop significantly.  Since Lipitor holds approximately 40% of the worldwide statin market, there will also be downward pricing pressure on  statins still under patent.

Generic manufacturers who stand to gain the most are:

• Ranbaxy
• Teva
• Watson
• Mylan
• Dr. Reddy's

Ranbaxy is the first to gain FDA approval of generic atorvastatin and will likely market through Teva in the U.S.

Watson, Mylan, and Dr. Reddy's are expected to enter the market at a later date.  Interestingly, Watson's product will be manufactured by Pfizer.

Obviously, Pfizer is set take the biggest hit in sales.  But, there are many other companies who will feel the impact in a negative way.  The list is quite impressive:

• AstraZeneca
• Novartis
• Merck
• Lilly
• Abbott

AstraZeneca's Crestor is the #2 selling statin.  Its sales of $5.69B represent a larger portion of their revenue than Lipitor does for Pfizer - 17% vs. 15.8%.  Crestor has been doing very well and is patented into 2016.

Novartis will be losing Lescol in 2012 and will rely on the sustained release version of Lescol -  Lescol XL - with patent expiration in 2019.

Merck already lost Zocor to generic competition, but managed to protect itself somewhat by creating a combination drug, Juvisync, with protection into 2017 at the minimum.

Lilly's entry, Livalo, has protection at least into 2015, and Abbott's Advicor at least into 2013.

Lost in the Lipitor news is Caduet's generic version being launched by Mylan this month.

Companies have sought to protect themselves from patent expiration by creating sustained release and combination forms of the drugs, but you have to seriously question whether medicare and the insurers will give those drugs a fighting chance when lower-cost, proven options exist.  This raises the bar for any future statins.