For those of you who take Enbrel to treat your arthritis and have been waiting for generic Enbrel to finally become available this year, we have bad news. Even though Amgen’s patent on Enbrel was due to expire later this year in October, it’s looking like generic Enbrel isn’t going to be available anytime soon.
Last year, Amgen was able to get the patent for Enbrel extended for another 16 years. Yes, that means that it is going to be at least another 16 years before it’s even possible for Enbrel to become available in the U.S. And Amgen still could try to fight to extend the patent again, which would keep generic Enbrel off the market even longer.
What’s more. Copying Enbrel as a generic may be easier said than done. For years, the most profitable drugs—mostly pills made of chemicals—have been fairly easy for generics companies to copy, requiring a straightforward chemical synthesis. But the next wave includes more-complicated inhaled drugs and others made of complex biological ingredients. Replicating them will require skills that many generics makers don’t yet have.
Enbrel is one of these biologic drugs which makes them extremely difficult to copy. As a “biologic,” Enbrel isn’t subject to the same laws and rules as traditional prescription drugs for generics. Because of the way that biologics like Enbrel are made, it’s currently very hard for competitors to make legal generic copies of biologics like Enbrel. Even if the laws regarding biologics change, Enbrel is protected by a that looooonnng extended patent now. At this rate, who knows when a cheaper, more affordable generic version of Enbrel will hit the market?
But even though developing a generic copy of Enbrel may be a tough row to hoe, it doesn’t mean that some major pharmaceutical companies aren’t trying. We’ll be crossing our fingers in the meantime.
Do you use Enbrel? Tell us about it!
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