Lipitor

What is Lipitor?

• Lipitor is a statin produced by Pfizer• Its generic name is atorvastatin calcium – Lipitor is the

proprietary name• It’s primary function is cholesterol control• It was discovered by Bruce Roth in 1985 (Warner Lambert) but

not released for another 15 years! (Year 2000)

Manufacturing & Marketing Companies & Competitors

• Pfizer are Lipitor’s primary producers• Ranbaxy intend to sell Lipitor as a generic when it loses its patent• Ranbaxy currently sell Lipitor in India under the brand name Atarvadel

• Lipitor’s man competitor is Crestor which is produced by Astra Zeneca (AZ)• Crestor is different from Lipitor in that it is a generic rosuvastatin and also contains

sulphur

Product Details (Mode of Action)Lipitor regulates the body’s cholesterol requirementsIt travels via the gastrointestinal route (human digestive system)It is administered orally It reduces the risk of cardiovascular diseases (strokes and heart attacks)

Manufacturing & Pakcaging Processes• Atorvastatin Calcium (white powder) – active pharmaceutical ingredient (API) in

Lipitor • It initially goes through the delumping milling process• It is then mixed with its excipients (inactive ingredients) and the next phase of the

process is wet granulation• The finished tablets are then dispensed into 20 kg drums and dispatched to an off-

site packaging contractor• Once the tablets have been received at the packaging facility they are either

placed in blister packs of 28 tablets or plastic bottles containing 90 tablets

Media Coverage

• “The Irish Times” edition of September 1st 2011 featured an article entitled “Sanofi plans generic cholesterol drug”

• Sanofi saw generics as a growth sector because a lot of their own products were losing their patents

• This is Sanofi’s initiative with regard to keeping employment in France• The French government gave Pfizer a tax break• The French corporate tax rate is 33.33% - 20.83% higher than the Irish rate of

12.5%!

How is Lipitor Regulated?• Lipitor is regulated by the US FDA’s CEDR and the IMB• Pfizer were served with a warning letter regarding an over emphasis on efficacy

claims in July 2001• Lipitor had a recall in October 2010 due to an uncharacteristic odour in specific

bottles of 40 mg Lipitor• Lipitor has been subject to counterfeiting • Counterfeit Lipitor has higher proportions of excipients than API’s• Pfizer’s Global Security seized 8.4 million counterfeit Pfizer

products in 53 countries• Pfizer works very closely with law enforcement agencies

in the war against healthcare criminals

Loss of Patent & Consequences

• Lipitor is set to lose its patent protection this year• This will see Lipitor's price fall by an average of 15%• The cost of Lipitor will be on a par with other generics and this will result in

increased competition between Lipitor and its competitors• As it is not unusual for generic drugs to be cheaper than innovator drugs (those

protected by patents) this will have a big impact on Pfizer and Lipitor’s sales