The Pharmaceutical Journal
Vol 270 No 7247 p603
3 May 2003

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First statin patent expires amid OTC speculation

Simvastatin (Zocor, Merck Sharp & Dohme) comes off patent on Monday. It is the first statin to lose its patent.

Generic competition drives down drug prices but the speed at which this happens varies. A spokesman for the British Generic Manufacturers Association said that prices can fall by as much as 50 per cent in the first year after patent expiry, depending on the number of generic entrants to the market. However, some industry insiders speculate that the price of simvastatin could fall more quickly, and by as much as 80 per cent.

John Beighton, chairman of the BGMA, told The Journal that there would probably be eight to 10 companies launching generic simvastatin. "However, some of the companies still have court action pending with MSD [concerning a supplementary patent] which will not take place until 10 June," he said. Whether this will deter the companies from launching their products, or if it will allow MSD to prevent the launches, remains to be seen.

Mr Beighton explained that simvastatin's supplementary patent relates to its impurity content. The companies involved in the court action admit that their products infringe this patent and they are trying to revoke it. However, his company — APS/Berk (owned by parent company Teva) — has successfully challenged the patent. "We have an agreement from MSD that our product does not infringe the patent and therefore we will be launching a generic simvastatin next Tuesday."

Among the other generic companies planning to launch simvastatin imminently are IVAX, Generics UK, Ratiopharm UK and Niche Generics.

Mr Beighton said: "There will obviously be some big savings for the NHS because simvastatin is a huge product. However, because of the uncertainties mentioned, we will not know exactly what will happen to the price of simvastatin for a few weeks." He adds that even if the prices do not fall by the same extent as has been seen in the past when patents have expired that there will still be significant savings for the NHS. "This is a good example of what generic companies do best. We save money for the NHS so that it can be made available to pay for the higher price innovative drugs which allows the innovative industry to flourish."

According to Prescription Pricing Authority data, statin prescribing has increased nearly five-fold in the past five years. The targets for lowering cholesterol levels set in the National Service Framework for Coronary Heart Disease mean this trend is unlikely to be reversed. The PPA also notes that simvastatin is the most frequently prescribed statin, followed by atorvastatin (Lipitor).

The current list price of Zocor is £18.03 (28 10mg tablets) and £29.69 (28 tablets, 20mg, 40mg and 80mg strengths).