Impax gets FDA approval for Mestinon Timespan generic
HAYWARD, Calif. — Impax Laboratories has received Food and Drug Administration approval for a generic version of Mestinon Timespan (pyridostigmine bromide extended release) tablets. The drug, intended to treat myasthenia gravis, will be available in 180-mg tablets. It is the first drug to be approved following Impax’s Sept. 4 resolution of issues outlined by the FDA in a warning letter to the company.
“We are pleased to receive approval of generic Mestinon Timespan Tablets, as this is the first generic product approved from the Hayward, CA facility following the resolution of the warning letter,” Impax CEO and president Fred Wilkinson said. “Our pending pipeline of 31 Abbreviated New Drug Applications at the FDA includes 17 products developed in Hayward. Although we cannot predict the timing of subsequent approvals, we are excited about the potential opportunities within our pipeline of products from this facility.”
According to IMS Health data, in the 12 months ending July 2015, Mestinon Timespan had U.S. sales of $45 million.
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Booming brand-name drugs contribute to growth
For the U.S. pharmaceutical market, 2015 is already shaping up to be another double-digit growth year in terms of prescription spend, according to IMS Health data. This year’s moving annual total spending has increased 12.7% to $399 billion, as of June.
One of the largest trends that will define this year is the boom in brand-name drugs — particularly specialty drugs and drugs to treat diabetes. Comparing the percent of spending they contributed to growth in 2011 (58%) to the 2015 MAT as of June (90%) underscores the dominance of branded drugs. In the 12 months ended June 2015, there has been a $19.8 billion increase in new-brand spending, and 75% of that is attributed to specialty medications.
Within specialty pharmacy, growth is particularly rapid in hepatitis C treatments. In the second quarter of 2015, hepatitis drugs spurred 3.3% of the total 13.5% growth in spending. Taking the first half of 2015, hepatitis C treatments have seen $9.6 billion in spending growth — a vast majority of which is for new and protected brands. There is a similar trend for diabetes drugs, which have seen $8.6 billion in growth as of June, with new and protected brands constituting almost the entirety of spending growth.
Despite the increase in money going to prescriptions, though, the growth of the total number of prescriptions being filled has been slowing for several years — only growing 0.1% between 2013 and 2014, with another 0.1% growth predicted based on the MAT from June. This has to do with the fact that despite the spending growth surrounding branded drugs, they still only constitute 16.8% of total prescriptions dispensed.