OBJECTIVES:  The Office of Generic Drugs (OGD) publishes bioequivalence (BE) guidances for specific products to support generic drug development. Each guidance describes the studies recommended for abbreviated new drug applications (ANDAs) that reference a particular new drug application (NDA). The purpose of this study was to evaluate the impact of BE guidance availability on the entry of generic competition when the reference product for a new molecular entity (NME) loses exclusivity. METHODS:  A cross-sectional study using exclusivity and patent data from the Orange Book published in 12/2016 was conducted. Other sources include product-specific BE guidances, Drugs@FDA, and National Drug Code directory. Exclusivity patterns, distribution of ANDAs approved after loss of exclusivity (LOE), patent term-related to NME NDAs, and BE guidances-related to NMEs were examined using descriptive statistics and chi-squared tests. RESULTS:  A total of 171 NME-associated NDAs with LOE between 7/28/2015-3/06/2027 were identified. The number of NMEs with LOE was highest in 2017 (n=34). As of 12/2016, LOE has happened for 33 NME NDAs; whereas 138 NME NDAs are still under their exclusivity period. Of the NME NDAs where LOE has happened, 12.5% have a generic approved/tentatively approved and the average number of ANDAs approved (±SD) per NDA is 2.25 (±1.89). For the remaining NME NDAs in this group with no generics, 82.14% are still under their patent term. Further, findings demonstrate that BE guidances were published prior to ANDA approval. On a yearly basis, BE guidances have been published for an average of 86.33% (±15.44%) of all NME NDAs. CONCLUSIONS:  Although BE guidances cover for the majority of NDA with NME exclusivity, exclusivity period, as well as patent term, may determine the entry of ANDAs into the market after LOE has happened. Further studies are warranted to analyze other factors that may impact ANDA entry.