On Thursday, July 19, 2012, Pfizer Pharmaceuticals along with Northwestern University won the first legal battle over the release of pregabalin, the generic formulation of Lyrica. Lyrica is an anticonvulsant which is approved to treat diabetic neuropathy, post herpetic neuralgia, partial onset seizures in adults and fibromyalgia. Recently, the FDA also approved its use for the treatment of neuropathic pain associated with spinal cord injuries.
Pfizer Pharmaceuticals and Northwestern University own the patents for the active ingredient pregabalin and its indications. Collectively, they filed patent infringement lawsuits in 2009 against several companies which applied to the FDA for approval to market a generic version of Lyrica before expiration of the patents. These defendant companies included TEVA of Israel, Lupin LTD and Sun Pharmaceuticals of India as well as Mylan and Watson from the United States. A trial was held in October of 2011 before Judge Sleet of the U.S. District Court of Delaware, but no decision was rendered at that time. The pharmaceutical companies involved reached an agreement not to put generic products on the market before July 20, 2012 or until Judge Sleet had rendered a decision, whichever came first.
On July 5, 2012, Lupin announced it had received final approval by the FDA for all strengths of its generic pregabalin capsules and planned to have them ready to be released by October 2013. Being the first company to have their generic formulation approved would afford Lupin an exclusive six month marketing advantage during which no other generic drug maker would be allowed to sell pregabalin.
Unfortunately for Lupin, even though they obtained FDA approval for their generic formulation, Judge Sleet’s decision of July 19, 2012 does not allow any manufacturer to market their generic version of Lyrica in the U.S. before December 30, 2018 when two of the patents expire. The FDA was also ordered to stop approving generic forms of pregabalin before Pfizer’s patents expire. The decision stops other manufacturers from tapping into Pfizer’s $1.8 billion growing market for Lyrica in the U.S. The overall impact of this decision on the workers’ compensation industry is that they will continue to have to pay brand pricing for Lyrica since a less expensive generic version cannot be released for six more years.
According to PMSI’s 2012 Annual Drug Trends Report for Worker’s Compensation, “the price for anticonvulsant use in workers’ compensation increased 5.8% in 2011 and was primarily driven by the AWP increase for Brand Lyrica which accounted for 31% of the total spent on anticonvulsants in 2011.” The report rated Lyrica as the the third highest in total spend and the eighth highest by total transactions out of the top 20 medications prescribed in workers’ compensation claims. With Lyrica’s recent approval to treat neuropathic pain associated with spinal cord injuries, the industry can expect to see a rise in its utilization in the coming years which will also drive up its cost.
The battle is not yet over as Lupin stated it plans to appeal the decision. It could be years before this issue is decided. Hopefully they will be successful so there will be opportunity for the industry to see the cost savings associated with the release of the generic equivalent. PMSI will be watching this matter to see what the ultimate outcome of the Lyrica litigation will be.