GSK, Amneal, Kaléo delist patents from FDA's orange book
Pharmaceutical companies, GSK (GSK), Amneal Pharmaceuticals (AMRX) and Kaléo have agreed to delist some of their patents from the FDA's orange book. GSK withdrew four inhaler patents and Amneal withdrew epinephrine injection patents. This comes after the Federal Trade Commission sent notices to several pharma companies for wrongfully-listed patents, which included AbbVie (ABBV), AstraZeneca (AZN), Boehringer Ingelheim, Impax, Kaléo, Mylan, GSK, and Teva (TEVA).
Yahoo Finance Healthcare Reporter Anjalee Khemlani discusses what this means for the pharmaceutical industry. For more expert insight and the latest market action, click here to watch this full episode of Yahoo Finance Live.
Video Transcript
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BRAD SMITH: Several pharmaceutical companies have pulled their patents from the FDA's database after the agency's recent crackdown. Let's bring in Anjalee Khemlani, Yahoo Finance's health reporter to discuss what this means for those companies and consumers. Hey, Anj.
ANJALEE KHEMLANI: Absolutely, hey, Brad. So we know that the FTC has been really locking into a lot of what pharma does, sort of minor deals, and ways that they extend their patents or look at ways to block generics from coming on the market. Now, this is what is at the crux of the move. The FTC, just a couple of months ago, letting companies know, sending out a letter to about a dozen companies letting them know that they were targets for possibly properly listing their patents in the FDA's Orange Book.
And so this is the first big win in that space for the FTC with three companies now delisting those patents, largely for EpiPens and inhalers. GSK, for example, letting go of four of its patents, de-listing those from that book. And it really speaks to what we've seen the FTC signal, which is that these practices from the industry are helping to keep costs high. And we heard FTC Chair Lina Khan really talk about that earlier this year saying, quote, "We've seen a whole set of deals that are below our radar, that are kind of slowly and incrementally consolidating a market."
That was in reference to smaller deals, M&A activity. But this is also part of the equation. Companies can use this strategy to extend the profits that they receive by about 30 months, in general, whenever a patent is listed in that Orange Book. So this really speeds up when generics can come to market and may also help spur more focus on certain areas where they feel, smaller companies especially, feel that may be blocked by these moves. So really interesting move for the FTC there.
- Very interesting. All right, Anj, thanks so much for breaking that down for us.
