Teva gets FDA OK to market generic Axert
- Teva will enjoy market exclusivity with its version of generic Axert (almotriptan) until Nov. 7.
- Axert is a a selective 5-hydroxytryptamine1B1D receptor agonist, which was first approved by the FDA in 2001 for treatment of migraine in adults.
- Almirall owns the rights to Axert, but Janssen markets Axert in the US.
The patent for Axert was supposed to expire in May. However, because Almirall was able to expand the indication in 2009 to include adolescents, exclusivity was effectively extended to November. The company's website features a marketing strategy that focuses on the option of using one migraine treatment for both adolescents and adults---using mothers and their teenage daughters as the centerpiece of the campaign.
The add-on of an adolescent indication, which expanded use of Axert to 12- to 17-year-olds, provided another six months of exclusivity, as well as a positioning opportunity for Janssen in the US market. Annual sales for Axert are roughly $31 million per year, but the introduction of Teva's generic version will most likely decimate sales.
- fdanews.com Teva First to Win FDA Nod for Generic Axert