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Authorized Generic Drugs: an Overview.

Z Gulsen Oner1,2, James E Polli3

  • 1Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.

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|June 27, 2018
PubMed
Summary
This summary is machine-generated.

Authorized generics (AGs) are identical to brand-name drugs but often cost less, though many are unaware of their availability. AGs impact patient finances and the pharmaceutical market, playing a significant role in healthcare.

Keywords:
180-day exclusivityU.S. Food & Drug Administrationauthorized generic druggeneric drug

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Area of Science:

  • Pharmaceutical Economics
  • Drug Marketing
  • Healthcare Policy

Background:

  • Authorized generics (AGs) are identical to innovator drugs but marketed under different names.
  • AGs typically offer lower costs to patients compared to brand-name drugs.
  • Widespread unawareness exists among patients and healthcare professionals regarding AG availability.

Purpose of the Study:

  • To increase reader familiarity with authorized generics (AGs).
  • To explore the financial and competitive impacts of AGs.
  • To review existing information on AGs.

Main Methods:

  • A comprehensive review of government documents was conducted.
  • A thorough literature review was performed.
  • Analysis focused on the role and impact of AGs.

Main Results:

  • AG marketing has, with some exceptions, benefited patients financially.
  • AGs are utilized in agreements between brand-name and generic manufacturers.
  • Regulatory policies for AG allowance and approval vary internationally.

Conclusions:

  • Authorized generics significantly influence the pharmaceutical market and patient costs.
  • AGs are a key component of the healthcare system, despite limited awareness.
  • Understanding AGs is crucial for navigating pharmaceutical economics and policy.