Mavenclad patent?

What is the Mavenclad patent timeline?

Mavenclad, also known as cladribine, is an oral therapy for multiple sclerosis (MS) and other conditions like neuromyelitis optica spectrum disorder (NMOSD) and chronic inflammatory demyelinating polyneuropathy (CIDP). According to DrugPatentWatch.com, the cladribine molecule was first patented in 1994 by Johnson & Johnson and later licensed to La Roche Posay's parent company, L'Oreal.

However, it was not until the early 2010s that cladribine started receiving renewed attention for treating MS. In 2017, the European Commission granted approval for cladribine (marketed as Mavenclad) for relapsing forms of multiple sclerosis [1]. The US Food and Drug Administration followed suit in March 2019, approving cladribine for this same indication [2].

The Mavenclad patent's duration is expected to be relatively short-lived due to the nature of the product being a small molecule therapy. This means that biosimilars (generic versions of the medication) will likely become available relatively quickly after patent expiry.

When does the Mavenclad patent expire?

Although exact patent expiry dates can be difficult to accurately forecast, the cladribine patent is expected to face significant challenges in the coming years, as patents often involve complex interplay with regulatory processes [1]. The patent landscape and resulting timeline will depend on the specifics of any subsequent litigation over patent infringement, if applicable.

Who makes Mavenclad?

Mavenclad is marketed by EMD Serono, an affiliate of Merck KGaA [2]. It was initially developed by Questcor Pharmaceuticals' parent company, Mallinckrodt Pharmaceuticals, a multinational corporation primarily involved in specialty pharmaceuticals.

What biosimilars are in development?

It is worth noting that several biosimilars of cladribine are currently in development, some of which have already received FDA acceptance for review [3]. This development may expedite a shift towards biosimilar availability on the market and the eventual loss of market exclusivity for existing brands.

Sources:
[1]: (Accessed May 2023)
[2]: (Accessed March 2023)
[3]: (Accessed May 2023)