In 2023, FDA ap­proves far few­er first gener­ic drugs than in re­cent years

Is the fall from the patent cliff fi­nal­ly over?

The FDA has sig­nif­i­cant­ly raised the bar when it comes to ap­prov­ing more and more gener­ic drugs every year, mak­ing the phar­ma­ceu­ti­cals mar­ket sig­nif­i­cant­ly cheap­er in the process. But so far in 2023, one im­por­tant met­ric that the agency tracks — the num­ber of first gener­ics to hit the mar­ket (i.e. first com­pe­ti­tion for a brand name drug) — has stalled for un­known rea­sons.

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