NDA drugs that are protected ONLY by NCE Exclusivity but NOT by patents (all patents have expired)?!! Though very few, but these are interesting products that took a very long time to reach the market. 

The report, published in Jan 2024, predicts the loss of exclusivities between 2024-2026 This is based on our Para IV Insights report. 

An article discussing the "Authorised Generics" strategy from the viewpoint of innovators. It provides empirical study on Authorised Generics launched over different time period and under varying circumstances. 

While patent offers protection to innovation, patent life decides the return on R&D investments. The Hatch-Waxman Act allows drug companies to request a single extension to their patent, limited to a particular length. Consequently, drug companies continue to extend their drug monopoly through such acts of “patent life cycle management.”

To be eligible for extension, Patent Term Extensions (PTEs) need to be applied within 60 days from the date of NCE approval. Hence PTEs are filed soon after the NCE approval but many years before the first Para IV application is filed. On the other hand, a decision on PTE may take 2-4 years, coming close on the heels of the first Para IV application. In other words, a Para IV applicant needs to closely monitor the PTE as its decision can alter the return expectations of the applicant. PTE also indicates which patents innovators plan to defend the most.  

The report lists the PTE petitions Filed, Accepted / Denied / Withdrawn in a given quarter. This is also integrated into our Para IV Insights database to ensure that our generic launch timelines become even more accurate.