The U.S. Food and Drug Administration (FDA) has approved a generic version of Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer, Glenmark Pharmaceuticals.
The FDA’s decision to approve the company’s application for teriflunomide tablets at two doses also makes Glenmark eligible for 180 days of shared generic drug exclusivity, a press release reports. Shared exclusivity can be granted for 180 days (about six months) to “multiple generic firms that are first to challenge different patents on the same drug,” the FDA notes.
Glenmark’s application was reported in the release to be the most complete submitted for teriflunomide tablets, providing clinical evidence of strength, dosage, quality, safety, and efficacy similar to its brand-name counterpart. This information supports a granting of exclusivity.
While generics have the same active ingredients and are required to work in the same way as brand-name medicines, they are less expensive because they carry lower development costs.
Glenmark has not yet released information regarding pricing for its generic teriflunomide tablets, or a likely date of availability in U.S. pharmacies.
Teriflunomide can inhibit the activity of an enzyme necessary for immune cells to proliferate and mature. With its particular mode of action, teriflunomide can prevent inflammatory reactions that are involved in damage to nerve cells that typify MS, particularly the loss of their protective myelin sheath.
Aubagio tablets were first approved in the Unites Stated in 2012 to treat relapsing forms of MS, and also approved for these patients in the European Union.
Results from two Phase 3 trials (NCT00751881 and NCT00134563) and two Phase 2 trials (NCT00489489 and NCT00475865) provided clinical evidence that 7 mg and 14 mg of Aubagio could effectively reduce the incidence of MS relapse events and prevent the risk of disease progression.
Long-term extension studies also demonstrated that treatment with Aubagio can slow brain tissue loss and improve cognitive outcomes.
Glenmark Pharmaceuticals, based in India, specializes in branded generic medicines. Its release states that the company currently has 142 products approved for distribution in the U.S.