Novartis’ Teva and Sandoz Launch Generics Narcan Same Day, Emergent Brand Marketing Stays On The Game – Endpoints News

Novartis’ Teva and Sandoz recently launched generic versions of Narcan on the same day, but it probably wasn’t a coincidence. The first two generics on the market of Narcan, an opioid overdose relief nasal spray, are approved by the FDA, but only the version of Sandoz is authorized by Emergent BioSolutions, the distributor of the Narcan brand.

Emergent, which acquired Adapt Pharma and Narcan nasal spray in 2018, is 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 generic of Narcan, but Emergent filed a complaint alleging that Teva infringed Adapt’s patents. A decision in 2020 ruled in Teva’s favor, but Emergent appealed. Last summer, a three-judge panel from the United States Court of Appeals heard the Emergent case but had yet to render a final decision.

Teva did not respond to questions about the launch schedule, but Emergent issued a statement noting the launch of Teva “ahead of the resolution of the related patent litigation.”

Emergent’s statement also highlighted her long history of working with public health officials to “educate and protect those who may be at risk of opioid overdose,” and said she welcomed additional solutions. to help fight the opioid epidemic. Emergent said it will update any 2022 financial effect when presenting year-end results.

In response to follow-up questions, a spokesperson for Emerg said the company does not anticipate any legal action in response to the Teva launch.

Meanwhile, Sandoz announced the launch of its generic Narcan licensed by Emergent on the same day as Teva in December. Asked about the timeline, a spokesperson said in an email that the launch was “based on our deal with Emergent.”

The licensed generic of Sandoz means that it is the exact same product as the brand name Narcan with a different label and sold at a generic price. The agreement with Emergent also guarantees the licensor of the brand a portion of these sales. Emergent in turn pays royalties to the creator of the Narcan nasal spray, Opiant Pharmaceuticals.

Along with the new Narcan generics, other drug manufacturers 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 the Adamis Pharmaceuticals FDA sign for Zimhi in October is an injectable dose. of 5 mg. On the horizon, there is potentially even more competition from Opiant itself. Its nasal nalmefene, another experimental treatment for opioid overdose, received fast track designation from the FDA in November.

What they’re all looking for is a slice of the sadly growing opioid overdose treatment market. Opioid overdose deaths increased by 40% during the pandemic from May 2019 to June 2020 – but even as the pandemic panic eases, the opioid epidemic is still raging. The CDC reported more than 75,000 opioid overdose deaths between April 2020 and 2021, a 35% increase.

Narcan’s emerging sales grew in tandem. Its most recent third-quarter revenue of $ 133 million was up 50% year-over-year. Nine-month sales reached nearly $ 314 million, already exceeding its total revenue of $ 311 million in 2020. Emergent has shipped 26 million Narcan devices to the United States since its inception in 2016.

In 2018, Adapt did regional television testing of a Narcan ad encouraging worried parents of young people on pain relievers to store the drug at home in the event of an accidental overdose. However, the 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 laws that allow direct sales to consumers through pharmacies.

However, neither Teva nor Sandoz intend to market Narcan generics to consumers.

A spokesperson for Teva said in an email, “We don’t market / promote generic products; they are prescribed in the form of a brand and then supplemented by doctors or pharmacies.

Sandoz simply stated that its generic Narcan is available “to people in the United States through retail pharmacies and institutions, including hospitals,” and added that its product website will contain resources for pharmacists.

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