The US FDA has approved the first generic version of atorvastatin–from Ranbaxy Laboratories. The generic is now available as 10-mg, 20-mg, 40-mg, and 80-mg tablets, manufactured by Ohm Laboratories .
Ranbaxy has exclusivity to market generic atorvastatin until May 2012, after which time many more generic versions will become available.
Atorvastatin has until now been available only as the branded Lipitor (Pfizer), which has been the world’s top-selling drug for several years. Last year, it had worldwide sales of $10.7 billion, of which $7.9 billion were in the US.
In an effort to keep some of its market share, Pfizer is producing an “authorized generic” product that is being marketed by Watson Pharmaceuticals. Pfizer has also agreed to deals with pharmacy-benefit managers to keep dispensing Lipitor for a time at generic prices. It has also launched a “Lipitor for you” program, which includes a card limiting a patient’s copayment to $4, valid until the end of 2012, with the company reimbursing the pharmacy the remaining copayment value.
Patients will benefit enormously from the availability of the lower-cost generics, with many more now being able to afford to take atorvastatin, which is a more potent statin than others that have been available generically. Insured patients will also be better off, as the insurance copay for generic drugs is much cheaper than that for branded drugs.
Lipitor/Atorvastatin – Atorvastatin is an oral drug that lowers the level of cholesterol in the blood. It belongs to a class of drugs referred to as statins, which includes lovastatin (Mevacor), simvastatin, (Zocor),fluvastatin (Lescol), and pravastatin (Pravachol). All statins, including atorvastatin, prevent the production of cholesterol in the liver by blocking HMG-CoA reductase, an enzyme that makes cholesterol. Statins reduce total cholesterol as well as LDL cholesterol in blood. LDL cholesterol is believed to be the “bad” cholesterol that is primarily responsible for the development of coronary artery disease. Reducing LDL cholesterol levels retards progression and may even reverse coronary artery disease. Atorvastatin also reduces the concentration of triglycerides in the blood and raises the concentrations of HDL (“good”) cholesterol. High blood concentrations of triglycerides also have been associated with coronary artery disease. The FDA approved atorvastatin in December 1996.