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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Regulatory Science

Background:

  • Manufacturers frequently develop modified versions of existing prescription drugs.
  • These new formulations can offer expanded patient treatment options.
  • However, they may also secure extended market exclusivity through later-expiring patents or data exclusivities, potentially delaying generic competition.

Purpose of the Study:

  • To determine the frequency of new drug formulation introductions by manufacturers.
  • To assess how often these new formulations gain additional market exclusivity beyond the original product's lifespan.

Main Methods:

  • A cohort design was employed using Food and Drug Administration (FDA) databases.
  • The study analyzed 17 new small-molecule drugs approved in 2002.
  • The introduction of new formulations and the timing of generic entry for both original and new formulations were tracked through 2017.

Main Results:

  • Twenty-one new formulations were linked to nine (53%) of the 17 drugs studied, with most introduced before 2007.
  • Generic entry occurred for six out of nine (67%) of these drugs.
  • For three cases, generic entry for the new formulations was delayed by more than two years compared to the original product.

Conclusions:

  • New formulations of brand-name drugs are introduced in approximately half of all cases.
  • The introduction of new formulations can sometimes grant manufacturers extended periods of market exclusivity, surpassing that of the original drug.