Teva set to launch generic EpiPen amid global shortage

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/ChesiireCat)
(Image: Getty/ChesiireCat)

Related tags: Pfizer, Mylan, Teva, EpiPen

Teva announced that its generic version of Mylan’s EpiPen product has been approved by the US FDA.

Teva’s epinephrine injector has become the first generic to reach the market, second only to Mylan’s generic version exceptionally launched in 2016 during the height of a pricing scandal​.

The branded version of EpiPen currently costs more than $600 (€525) for a pack of two injectors in the US while the launch of Mylan’s generic version saw it receive a price tag of around $320.

Where Teva will price its own approved product is a major source of interest; however, a spokesperson from Teva only told us that it had “not yet publisheda list price”​.

The spokesperson offered a company statement suggesting it would be “applying [its] full resources to this important launch in the coming months and [is] eager to begin supplying the market.”

The approval marks another step by the US Food and Drug Administration (FDA) to curb the prices of certain products by encouraging the development and application of viable generics.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,”​ said FDA commissioner Scott Gottlieb.

The news for Teva follows on from this month’s news that Apotex received an approval​ through the Competitive Generic Therapy designation, in a first for the industry.

Timing is everything

The point at which the FDA has approved the generic product could pose a particular challenge to Mylan.

Pfizer, which manufactures the drug for Mylan, has experienced major manufacturing difficulties; this has led to a shortage of supply in North America​ and also in other regions of the world​.

This represents an opportunity for Teva to fill this vacuum but the timing could also see the company miss out on a significant window for sales – the return-to-school period at the beginning of September, in most countries.

Teva’s EpiPen generic will not be the first epinephrine injector alternative to reach the market, after Kaleo re-launched its Auvi-Q product​ and Adamis received the nod​ for its Symjepi equivalent.

Related topics: Regulatory & Safety, Regulations

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