Teva and Novartis’ Sandoz launch Narcan generics on same day, brand marketer Emergent remains in play
Teva and Novartis’ Sandoz recently launched generic versions of Narcan on the same day, but it likely wasn’t a coincidence. Both first-to-market generics for Narcan, an opioid overdose rescue nasal spray, are FDA approved, but only Sandoz’ version is authorized by Narcan’s brand marketer Emergent BioSolutions.
Emergent, which acquired Adapt Pharma and the Narcan nasal spray in 2018, has been in a protracted patent litigation with Teva over its generic version. The FDA approved Teva’s naloxone hydrochloride nasal spray in April 2019 as the first Narcan generic, but Emergent filed a lawsuit alleging Teva infringed on Adapt patents. A decision in 2020 ruled in favor of Teva, but Emergent appealed. This past summer a three-judge US Court of Appeals panel heard Emergent’s case but had yet to render a final decision.
Teva didn’t answer questions about the launch timing, but Emergent released a statement noting Teva’s launch “prior to resolution of the related patent litigation.”
Emergent’s statement also pointed out its long history working with public health officials to “educate and safeguard people who may be at risk of an opioid overdose,” and said it welcomes additional solutions to help fight the opioid epidemic. Emergent said it will update any 2022 financial effect when it presents year-end results.
In response to follow-up questioning, an Emergent spokesperson said the company is not planning any legal action in response to the Teva launch.
Meanwhile, Sandoz announced the debut of its Emergent-authorized generic Narcan on the same day as Teva in December. When asked about timing, a spokesperson said in an email that the launch was “based on our agreement with Emergent.”
The authorized generic from Sandoz means it is the exact same product as the branded Narcan with a different label and sold at a generic price. The deal with Emergent also ensures the brand licensor a portion of those sales. Emergent in turn pays royalties to the originator of the Narcan nasal spray, Opiant Pharmaceuticals.
Along with the new Narcan generics, other drugmakers have entered the naloxone hydrochloride nasal spray market through different dosing mechanisms. Narcan is a 4-mg spray dose, but Hikma Pharmaceuticals got its FDA approval for Kloxxado in April for an 8-mg intranasal dose while Adamis Pharmaceuticals’ FDA nod for Zimhi in October is a 5-mg injectable dose. On the horizon is potentially even more competition from Opiant itself. Its nasal nalmefene, another investigational treatment for opioid overdose, secured an FDA fast track designation in November.
What they’re all pursing is a slice of the unfortunately growing opioid overdose treatment market. Opioid overdose deaths increased 40% during the pandemic from May 2019 through June 2020 — but even as pandemic panic eases, the opioid epidemic is still raging. The CDC reported more than 75,000 opioid overdose deaths from April 2020-2021, an increase of 35%.
Emergent sales of Narcan have increased in tandem. Its most recent third quarter sales of $133 million notched a 50% increase year-over-year. Sales through nine months were almost $314 million, already topping its full 2020 revenue of $311 million. Emergent has delivered 26 million Narcan devices in the US since its 2016 debut.
In 2018, Adapt did some regional TV testing of a Narcan ad encouraging concerned parents of young people on pain meds to stock the med at home in case of accidental overdose. However, marketing of naloxone in general has been limited to direct appeals to public health officials in communities, first responder organizations and hospitals. Most states have adopted laws that allow direct sales to consumers at pharmacies.
Still neither Teva nor Sandoz have plans to market the Narcan generics to consumers.
A Teva spokesperson said in an email, “We don’t market/promote generic products; they are prescribed as name-brand and then supplemented by doctors or pharmacies.”
Sandoz simply said its Narcan generic is available “to people in the US via retail pharmacies and institutions, including hospitals,” and added that its product website will feature resources for pharmacists.