There are many medications that can be used in the management of multiple sclerosis. Medications range from those that must be administered by infusion or self-administered injectable agents to oral agents. Currently, this is a very brand-dominated category with only Ampyra® (dalfampridine), Copaxone® (glatiramer), and most recently Tecfidera® (dimethyl fumarate), available in generic forms. Multiple sclerosis continues to be an area of interest for clinical development with companies searching for new products so we expect the brand trend to continue.
The launch of Mylan’s dimethyl fumarate was determined to be an “at risk” launch. What this means is that essentially, although Mylan did receive FDA approval for the product, there is still a chance that patent litigation could end up overturning the ability of Mylan to market the generic. At this point, it seems like Mylan has the advantage and the product should remain available.
Through the patent challenge and approval process that was taken by Mylan, they are currently the only company who has received FDA approval for generic dimethyl fumarate.
Being the only generic available, there has been a very moderate (about 10%) reduction in the price compared to brand Tecfidera®.
A number of other companies have continued to push forward with bringing generic dimethyl fumarate to market. If these companies succeed in getting approval, ultimately this should drive down the cost of therapy. There also has been some discussion as to whether or not Mylan will have exclusive rights to manufacture the generic for a specified time. This determination is pending the ongoing litigation and could have an impact as to how fast generic to generic competition occurs.
Many sources have predicted that we could see the annual cost of therapy go from over $100,000 with brand Tecfidera® to under $10,000 based on a switch to generic within a year. At this point, there are still a fair number of unanswered questions on if or when that will happen. From my seat, I am optimistic that the decisions and current patent challenges will favor the generic manufacturers and hopefully get us to lower costs sooner than later.
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