As a result of settlement agreements with the brand manufacturer, Sanofi, several generic companies have been approved by the U.S. Food and Drug Administration (FDA) to introduce generics for Aubagio® (teriflunomide) tablets in the U.S. The first to announce a launch for its generic is Accord Healthcare US. However, Sola Pharmaceuticals, Teva Pharmaceuticals USA, and Zydus Pharmaceuticals USA list teriflunomide as available for purchase in their product catalogs, as well. The pyrimidine synthesis inhibitor is taken once a day to treat adults who have relapsing forms of multiple sclerosis (MS). No information currently is available about the launch plans of the other companies. Sanofi’s 2022 annual report estimated that U.S. Sales for Aubagio amounted to $1.4 billion for the year.
At a Glance
- Brand (Generic) Name: Aubagio (teriflunomide)
- Generic Manufacturers: Accord, Sola, Teva, and Zydus all offer teriflunomide for sale in their product catalogs, with more manufacturers expected to join in the near future.
- Launch Date: March 13, 2023
- Indication: for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS), in adults
- Dosage Forms Available: 7mg and 14mg oral tablets
- The National MS Society estimates that about one million Americans have MS. Approximately three-quarters of patients are women and diagnoses most frequently are made when patients are between the ages of 20 years old and 50 years old.
- An autoimmune disease, MS attacks the coverings of nerves in the central nervous system (CNS). Nerve damage leads to the progressive worsening of a wide range of physical symptoms including dizziness, fatigue, muscle weakness, spasms, and vision problems. Most patients have mental health issues, as well, such as depression, anxiety, and cognitive problems.
- Teriflunomide interferes with an enzyme that promotes inflammation associated with MS.
- Its labeling has boxed warnings that it may cause damage to the liver and to unborn babies. All individuals who take teriflunomide should have liver function tests before treatment starts, every month for at least the first six months of therapy and then periodically as long as they take the drug. Women who are of childbearing age should have negative pregnancy tests before beginning to take teriflunomide and they should use reliable methods of birth control while treatment with it lasts.