‘The defendants are enjoined, based on this infringement, from commercially manufacturing, using, offering for sale, or selling’ their product, and FDA is prohibited from approving the generic drug applications until the patents expire, US District Judge Gregory M Sleet wrote in a 133-page opinion.

According to Ms Amy Schulman, Pfizer’s General Counsel, ‘the court’s decision recognises the infringement and validity of our Lyrica patents and affirms the value of Lyrica as a distinct and important innovation for patients.’

Other manufacturers named in the case were Actavis, Sun Pharma Industries, Watson Pharmaceuticals and Wockhardt USA.

Lyrica was approved by FDA in 2004 and is used to treat fibromyalgia, diabetic nerve pain and pain after shingles, as well as partial onset seizures, anxiety, epilepsy and restless-leg syndrome. Sales of Lyrica reached US$3.7 billion in 2011.

The ruling follows a previous patent infringement victory for Pfizer in 2011 in which Teva was banned from marketing a generic version of blockbuster impotence drug Viagra (sildenafil citrate), until 2019.

Teva is in the top 15 global pharmaceutical companies, and made US$18.3 billion in sales in 2011, according to the company’s website. Sales in the first quarter of 2012 reached more than US$5 billion, an increase over the previous year. Among Teva’s brand-name products is Copaxone (glatiramer acetate), for the treatment of relapsing-remitting multiple sclerosis. One of its top selling generic products is the cholesterol-lowering agent simvastatin.

Related article

GPs in the UK to be banned from prescribing branded statins