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The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications. The study focused on abbreviated new drug applications (ANDAs) submitted to the FDA, relying on existing reference (approved) drug products. The researchers analyzed data for 400 brand-name drugs, of which 140 were new chemical entities (NCEs) and 260 did not have NCE exclusivity.
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Key findings of the study
1. For NCE drugs, ANDA submissions were more likely to occur if the brand-name drug had generated higher revenues. Market exclusivity resulting in annual revenues greater than $250 million for up to four years after approval significantly increased the likelihood of an ANDA submission.
2. The designation of a brand-name product as a complex drug (due to its structure, composition, or delivery method) negatively affected ANDA submission for both NCEs and non-NCE drugs.
3. The availability of a published product-specific guidance (PSG) before an ANDA submission was strongly associated with an increased likelihood of ANDA submission for non-NCE drugs.
4. Patents did not significantly impact the likelihood of ANDA submission.
Implications and Advancement
The study highlights the importance of timely development of PSGs, especially for complex generics, to facilitate ANDA submissions and promote drug price competition. Increased generic drug competition can lead to more affordable therapies for patients, aligning with the FDA’s mission.
This retrospective study provides valuable insights for the FDA in understanding the effects of its practices and policies on generic drug development. By identifying factors influencing ANDA submissions, the FDA can enhance its efforts to advance generic drug development and improve access to cost-effective medications.