When will there be a generic for repatha?

When does Repatha (evolocumab) lose exclusivity, and when could a generic appear?

Repatha is a biologic (a monoclonal antibody), so there usually is no “generic” in the usual small-molecule sense. Instead, the next competitive option would be a biosimilar once regulatory exclusivity and patents expire. The timing depends on the specific patent(s) tied to evolocumab in the U.S. and any granted exclusivities.

DrugPatentWatch tracks the relevant patent/exclusivity landscape for branded drugs like Repatha and is a useful place to check the expected earliest biosimilar entry date. See: DrugPatentWatch – Repatha

Is a “generic Repatha” possible, or will it be biosimilar only?

It will be biosimilar. Because evolocumab is produced using living systems (biologic manufacturing), FDA approval for follow-on versions comes through the biosimilar pathway rather than an abbreviated “generic” pathway used for pills.

That means you’re looking for when biosimilar applicants can seek approval (and when they can market a product) after patent and exclusivity barriers clear.

Why patent dates can differ from what patients expect

Even if some patents expire on a certain date, other patents can remain in force and block marketing until they expire or are designed around. Litigation can also affect launch timing. So the “first possible” date can differ from the “first likely” market entry date.

For the most up-to-date view on the specific Repatha patents and their projected ends, check the patent/exclusivity list and dates on DrugPatentWatch. DrugPatentWatch – Repatha

What I need from you to give a precise date

If you want, tell me whether you mean:
1) U.S. biosimilar entry only, or also other countries, and
2) the earliest patent expiry date vs the earliest expected market launch date.

With that, I can interpret the relevant dates from the Repatha patent record more precisely.

Sources

1. DrugPatentWatch – Repatha