Teva launches generic EpiPen in the U.S.

Teva has begun a limited U.S. commercial launch of its generic version of Mylan’s EpiPen epinephrine autoinjector, with the 0.3-mg version being made available to the public at a wholesale acquisition cost of $300, the same price as Mylan’s own authorized generic launched almost two years ago.

Additional supplies of Teva’s generic, as well as its version of the EpiPen Jr, at 0.15 mg, are expected to be available in 2019, the company said.

Teva received an FDA approval of its generic version in August, following delays of more than two years.

The approval came while EpiPens were in short supply, with shortages continuing after FDA investigators found problems last year at a Meridian Medical Technologies plant, a Pfizer subsidiary that manufactures the autoinjectors for Mylan.

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In May, the agency added the EpiPen and injectors from Impax Laboratories to its drug shortages list, after Mylan recalled 80,000 possibly faulty injectors shipped outside the U.S.

The FDA has previously approved competitors to Mylan’s EpiPen under new drug applications, such as Amedra Pharmaceuticals’ Adrenaclick and Kaleo’s Auvi-Q.

In addition, Novartis’ Sandoz unit recently acquired the U.S. rights to Symjepi, a prefilled epinephrine syringe from Adamis Pharmaceuticals.

Novartis has decided to jump onto EpiPen’s playing field. The Swiss drugmaker’s Sandoz unit snapped up U.S. rights to Symjepi, the Adamis Pharmaceuticals prefilled epinephrine syringe, positioned as a low-cost alternative to autoinjectors.