- Teva has launched a generic epinephrine autoinjector at a price of $300 per pack of two, matching the cost of Mylan's authorized low-cost version of its flagship EpiPen brand.
- Teva has released limited doses of the 0.3 mg autoinjector, though it is not clear what quantity this indicates. The children's version (0.15 mg) and additional supplies of the 0.3 mg autoinjector will be available in 2019, according to the company.
- EpiPen supplies have been patchy as Mylan faced production issues. Teva's supplies are limited at the moment, so its entry onto the market may not have a major commercial impact.
In August, Mylan issued an update on its ongoing supply woes for both its branded and authorized generic forms of EpiPen, which stemmed from manufacturing issues at Pfizer subsidiary Meridian Medical Technologies. Supplies were varying from pharmacy to pharmacy, and Pfizer said the company was "working tirelessly to increase production and expedite shipments as rapidly as possible."
That disruption is one factor in the commercial struggles Mylan has faced. Sales from the drugmaker's North America segment were down 14% in the third quarter of 2018, driven in part by lower volumes of EpiPen.
Teva's generic version, meanwhile, picked up Food and Drug Administration approval in August, making it the first direct copycat of the EpiPen and EpiPen Jr autoinjector approved by the agency.
A key competitor for both Mylan and Teva is Kaléo's Auvi-Q, which was approved under a New Drug Application last November.
Epinephrine autoinjectors are still in shortage, according to data from FDA's drug shortage website. Mylan reverified its supply troubles Nov. 23.
Kaléo has been unaffected by manufacturing challenges, and also recently received a boost from a deal with Walgreens. Commercially insured patients eligible for Kaléo's patient support program will get the pen at no out-of-pocket cost at Walgreen's almost 10,000 locations. The list price sits at $4,900, but Kaléo claims that many patients get the drug-device combination for $360 cash — and sometimes for nothing out of pocket. Kaléo also has FDA approval for a 0.1 mg Auvi-Q autoinjector designed for infants and toddlers, the first approved for this age group.
Another potential rival in the space, Adamis Pharmaceuticals' Symjepi, also picked up approval in 2017.