Loss of Exclusivity App

Marbls, LLC

About this app

BACKGROUND

One critical aspect often overlooked by the Life Sciences industry is the management of Loss of Exclusivity (LoE). LoE represents a pivotal point in a product's lifecycle when market exclusivity ends, opening the door to generic competition. Proactive and effective LoE management is crucial for Life Sciences companies to navigate the complex landscape of transitioning from exclusivity to competition. Marbls' mobile app allows pharmaceutical manufacturers to anticipate regulations applied with an upcoming and post-LoE on the originator and its entering competitors.
These regulations often establish:
- Mandatory price cuts and discounts
- Substitution and prescription policies
- IRP rule changes
- Price Transparency risks, etc.


THE CHALLENGE

However, there is a lack of uniformity among the regulations imposed by each European country. For example, mandatory price cuts often have different ranges and will occur at different points in time and the changes to the IRP rules impacting the organization should be considered to allow for proper forecasting.


OUR APP AS A SOLUTION

Marbls has created a mobile app to aggregate the regulations applied post Loss-of-exclusivity (LOE) in European countries. The app enables users to access all current and upcoming regulations around Loss-of-exclusivity (LoE) in one place. Users can find detailed information on specific regulations in each country as well as information on regulations that may be forthcoming. The app is updated bi-monthly, providing up-to-date information on legislative activity.

What’s new

- Added the MFN feature to Pricing Search: Most Favoured Nation (MFN) links pricing and access conditions across various countries, where changes in one market can trigger global impact, especially after Loss of Exclusivity. The Marbls LoE app provides clear visibility into countryspecific regulations, mandatory price dicounts and reimbursement rules shaped by MFN. Use it to proactively assess cross-market impacts, reduce uncertainty, and make informed, compliant decisions.
- Minor UI update