- Teva has priced its epinephrine autoinjector at $300, staking its claim in the EpiPen generic market and matching the price of Mylan's authorized generic. That's about half the list price of the original EpiPen.
- Teva has released limited doses of the 0.3 mg autoinjector, though it is not clear what quantity this means. 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 has faced production issues. Teva's supplies are limited at the moment, so its entry onto the market may not have a major impact for the supply chain and for patients.
Back in August, Mylan issued an update on its supply woes for both its branded and generic forms of EpiPen, caused by manufacturing issues at Pfizer subsidiary Meridian Medical Technologies. Supplies were varying from pharmacy to pharmacy, and Pfizer stated that the company was "working tirelessly to increase production and expedite shipments as rapidly as possible."
Mylan's North America segment sales were down 14% in the third quarter of 2018 and 18% in the first nine months of the year, driven at least partly by the lower volumes of EpiPen sales.
Teva picked up the Food and Drug Administration approval in August, making it the first generic version of EpiPen and an "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 (NDA) 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 has 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 is an eye-watering $4,900, but Kaléo claims that many patients get the drug-device combination for $360 cash, or even for nothing. 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 its approval in 2017 under an NDA.