We all are aware that the first day of Para IV filing on any NDA is exactly one year before the NCE exclusivity of the NDA expires. In other words, NCE – 1 expiry of an NDA is the day on which a first Para IV filing can happen.
As a result, NCE – 1 is actively tracked by all the generic companies for all the new NDAs. However, no one knows about the name of generic companies targeting specific NDAs for Para IV filing.
This report brings you the names of those generic companies that are targeting NDAs whose NCE – 1 is expiring between October 2024 and December 2025 (NCE expires between October 2025 and December 2026). These are those generic companies who we believe are at some stage of generic development of their respective NDA (Generic developer cos).