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Prevalence and timing of authorized generics in the US market

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Copyright © DrugPatentWatch. Originally published at

A recent study explores the landscape of authorized generics in the United States pharmaceutical market. Authorized generics are brand-name drugs that are marketed without their original branding. The article sheds light on the trends, launch timing, and characteristics of these authorized generics in comparison to traditional generics.

Authorized Generics Launch Trends

  • Many authorized generics are launched strategically after the approval of the first generic version of the corresponding brand-name drug.
  • Around 70% of authorized generics were launched before or during the 180-day exclusivity period for eligible generics.
  • The timing of authorized generic launches often appears to be influenced by the competitive landscape.

Brand-Name Drug and Authorized Generic Relationships

  • Authorized generics are identical to brand-name drugs but are marketed without the brand names on their labeling.
  • They can be sold directly by the same company as the brand-name drug, a company owned by the brand company, or a company under license from the brand company.

Long-Term Impact on Competition and Access

  • While authorized generics may improve drug access in the short term and offer lower prices, they could potentially hinder generic competition in the long run.
  • The empirical evidence on whether authorized generics are beneficial or harmful to consumers in the long term is limited.
  • Some authorized generics are strategically launched during periods of higher revenues or are discontinued after a certain time.

Strategic Timing and Competition

  • Authorized generics are often introduced when the threat of generic entry is heightened, particularly after the approval of the first traditional generic version for the brand-name drug.
  • Some authorized generics launch before the first generic entry, which could be driven by various business considerations.

Implications for Research and Policy

  • The findings provide insights for future research on the effects of authorized generics on competition, prices, and access to generics.
  • The study’s comprehensive data set allows for a better understanding of authorized generic launches and their impact on the pharmaceutical market.

These findings shed light on the strategic nature of authorized generic launches and their potential impact on the pharmaceutical landscape, including both competition and consumer access to drugs.

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Copyright © DrugPatentWatch. Originally published at
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