Predicting Generic Drug Marketing Applications

FDA announced on Oct. 28, 2020 that researchers at the Center of Drug Evaluation and Research (CDER) have studied factors that might predict the possible submission of an abbreviated new drug application (ANDA). CDER researchers used proprietary data related to ANDAs, internal or public information, and information on drug sales to see if a drug’s characteristics, regulatory history, or market sales could predict the submission of an ANDA. The study separately analyzed drugs that were originally approved as new chemical entities (NCEs) and those that did not have NCE exclusivity.

The study found that ANDAs were more likely to occur in NCEs and non-NCEs that had higher revenues. “By contrast, designation of a brand-name product as a complex drug (for example, due to its structure, composition, or its mode of delivery) was negatively associated with ANDA submission for both NCEs and non-NCE drugs,” FDA stated in a press release. Challenges associated with complex drug substances or drug products may be a factor, according to the researchers.

Data showed that the availability of a published product-specific guidance (PSG) for non-NCE drugs was a positive factor in ANDA submissions. “Non-NCE drugs for which there was a PSG were approximately 3.8 times more likely to result in an ANDA submission than non-NCE drug products for which no PSG had been published (data not shown),” FDA stated. The study also found that patents did not have a significant impact on ANDA submissions. “…in the case of large-revenue drugs, that sponsors will challenge the patent even when they are unlikely to win, meaning that higher sales are associated with more pre-generic approval patent challenges (commonly referred to as ‘Paragraph IV’ challenges).”