Lifecycle management: rethinking proven active ingredients when patent protection ends

The patent cliff

When the patent on a successful drug expires, generics enter the market and sales of the original usually fall sharply. According to Laxxon Medical, more than 150 drugs with combined sales of over 100 billion US dollars will lose patent protection in the next ten years.

Improvement, not a copy

Lifecycle management refers to strategies with which manufacturers preserve the value of an active ingredient beyond the original patent term. A central lever is an improved dosage form: a formulation that needs to be taken less often, a combination of several active ingredients, or a form that is easier to swallow. This only works if the innovation brings a real benefit to patients.

Regulatory and legal levers

In the US, such a new formulation can be submitted via the 505(b)(2) route, which relies in part on existing data on the known active ingredient. If the change meets certain conditions, three years of market exclusivity are possible.

Then there is protection of the new formulation itself. Laxxon states that all products made with SPID® are patent-protected, whether developed in-house or with partners. When Evonik invested in 2022, the company already stressed that the technology could extend patent protection for existing drugs; Adare also names potentially longer protection of intellectual property as an advantage of the process.

Three ways to work together

Laxxon pursues several models: licensing the technology to pharmaceutical companies, development services up to a manufacturable product, and its own pipeline of so-called Advanced Patented Generics. According to the company, the pipeline currently comprises 13 own products and three projects developed for external customers.