Pfizer gets tough with Lipitor fakers
campaign against the trade in counterfeit versions of its
top-selling drug Lipitor (atorvastatin), one of the most copied
drugs on the market.
The pharmaceutical major has filed lawsuits against a second group of operators of 18 Internet sites in the US for selling unapproved and illegal copies of the cholesterol-lowering medicine.
Lipitor is the world's top-selling drug - racking up sales of $4.86 billion in the first six months of this year, and is a prime target for counterfeitiers. Last year, a US drug distributor was forced to recall 1.8 million tablets labelled as Lipitor after coming across fake batches of the drug. A spokesman for Pfizer quizzed recently by In-Pharmatechnologist.com declined to comment on the cost of these actions, but said the company was most concerned about the damage to the public's perception of the security of the drug supply.
Pfizer said the sites market products identified as 'generic Lipitor' or 'Lipitor generic', which are not legitimate medicines. Lipitor remains patent-protected and no generic versions of the drug are legally available in the US.
More worryingly, tests performed on tablets obtained from two of the web sites showed that they contained no active ingredient, and so would provide no therapeutic benefit to patients, noted the company, which has advised the US Food and Drug Administration of its findings.
Meanwhile, the FDA has stepped up its own campaign against drug counterfeiting, by calling for the introduction of improved 'track and trace' technologies, notably radiofrequency identification (RFID). Moreover, last week the agency successfully prosecuted two wholesale firms for failing to provide required safeguards for ensuring supply chain integrity, including the monitoring of drug pedigrees.
All the lawsuits seek injunctions against further sales of 'generic Lipitor' or 'Lipitor generic' and claim damages for infringement of Pfizer's trademark rights.
The complaints also seek to remove references to Lipitor in advertising materials and to eliminate computer links that misdirect patients to illegal, unapproved products. In addition, Pfizer has filed patent infringement claims against 10 site operators to recoup damages and to prevent further sales of the bogus wares.
Meanwhile, in Europe, Pfizer is adding tamper-evident packaging across its range in a bid to make it harder for counterfeiters to copy its drugs. And in common with other drugmakers it is also exploring the use of various track-and-trace technologies, including RFID, to shore up security in the supply chain.
