Aubagio is a medication used for treatment of patients with relapsing forms of multiple sclerosis and is owned by Sanofi. It contains the active ingredient Teriflunomide. It was first authorized for medical use in 2012. The global multiple sclerosis drug market was valued US$ 29 billion in 2023. There were 6 drug patents protecting Aubagio in United States, but as of now none of those patents have expired.
Aubagio (Teriflunomide) currently had patent protection until August 04, 2034. This means Aubagio generic will be available in the market after August 04, 2034, unless a Paragraph IV certification was filed challenging the patents before expiration.
Aubagio is approved to treat relapsing forms of multiple sclerosis (MS) in adults. The active ingredient in Aubagio, Teriflunomide, is an immunomodulator that inhibits dihydroorotate dehydrogenase, an enzyme involved in the de novo pyrimidine synthesis pathway. This reduces proliferation of T and B lymphocytes thought to be involved in the pathogenesis of MS. Aubagio is administered orally to modulate the immune system systemically rather than targeting a specific site.
Aubagio currently holds 6 patents covering teriflunomide active ingredient, formulation, and methods of treatment. With patent protection extending as late as 2034, Aubagio is unlikely to face generic competition until the late 2030s after all patents and exclusivities expire. Below is a list of the recent Aubagio patent expirations -