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).

The FDA Reauthorization Act of 2017 has created a new type of 180-day exclusivity, different from 180-day patent challenge exclusivity, for the first approved applicant of a drug with a CGT designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of the ANDA. This new 180-day exclusivity, under CGT exclusivity is intended to incentivize competition for drugs that are not protected by patents or exclusivities and for which there is inadequate generic competition.

This report forecasts the upcoming eligible CGT exclusivity drugs between 2025-2028 and generic manufacturers targeting those drugs. The report is prepared from our GenUS database. 

The report includes our forecast of Loss of Exclusivities in US between 2025 through 2027.

Despite commoditization of the Para IV space, it still continues to attract all major generic manufacturers globally. As a result, ~$50 bn of sales will lose its exclusivity over next 3 years. Out of these total ~$50 bn in sales, ~50% will be exposed in 2025 alone – thanks to 3 biologics losing exclusivity in 2025.

While Indian companies continue to dominate this space, large international companies like Teva, Apotex, Mylan and Sandoz maintain its ranking among the top 10 generic companies with Para IV filings.

Interestingly, competitive intensity among Para IV Filers is reducing with the share of sole FTF holders rising significantly from 2025 to 2027.