California teams up with New Jersey company to make generic drug to reverse opioid overdose

SACRAMENTO, Calif. — California will soon begin selling its own generic version of Narcan, the drug that can save someone’s life during an opioid overdose under a deal announced Monday by Democratic Gov. Gavin Newsom as part of his effort to provide less expensive state brand drug options.

New Jersey-based Amneal Pharmaceuticals will sell naloxone in California for $24 a pack, or about 40% cheaper than the market rate. California plans to give away many of the kits for free to first responders, universities and community organizations through the state’s naloxone distribution project.

But it will also sell some of the packages at a discount rate to California businesses and local governments as long as they agree not to mark up prices and sell them for a profit. The goal is to expand distribution beyond schools and public health departments and into places like restaurants, entertainment centers and ride-hailing services like Uber and Lyft.

Any place that has a first aid kit, we hope that this product will be available as part of that, said Elizabeth Landsberg, director of the California Department of Health Access and Information, which oversees the program.

Naloxone nasal spray will be the first drug to carry the CalRx label, Newsom’s effort to force drug companies to lower their prices by offering far less expensive competing versions of life-saving drugs. Newsom first announced the idea in 2019 and signed a law giving California the authority to do so in 2020.

This isn’t the first time California has made its own medication. Since 2003, the California Department of Public Health has manufactured a treatment for the rare disease of infant botulism. But state officials say they believe California will be the first state to distribute a generic drug under a state label.

Federal and state governments can and should use their power as regulators and as buyers, said Anthony Wright, president of the consumer advocacy group Health Access California. “Americans who pay out-of-pocket for prescription drugs pay more than anyone else in the world, but if the government can use our collective power of the purse through direct contracting and manufacturing, we can get better deals not just for taxpayers , but also for patients and the public as a whole.

Naloxone has been available in the US without a prescription since March 2023, when the US Food and Drug Administration approved Narcan, a brand of nasal spray produced by Maryland-based pharmaceutical company Emergent BioSolutions.

Amneal Pharmaceuticals makes a generic equivalent to Narcan that won FDA approval last week.

The naloxone packs purchased by California will initially be available under the Amneal label. Naloxone will go on the CalRx label once it is approved by the U.S. Food and Drug Administration, a process the Newsom administration said could happen by July.

We have enabled through CalRx the manufacture of a low-cost (over-the-counter) naloxone option that without us may not have reached the market as quickly or in this volume, said Dr. Mark Ghaly, the Agency’s Secretary of California Health and Human Services.

The deal is important because it means California will be able to buy far more than 3.2 million naloxone packs in a year instead of 2 million for the same total cost.

Opioid overdose deaths, which are caused by heroin, fentanyl and oxycodone, have increased dramatically in California and across the country. Annual opioid overdose deaths in California doubled since 2019, reaching 7,385 deaths by the end of 2022.

California began giving away free naloxone kits in 2018. State officials say the Naloxone Distribution Project has given out 4.1 million kits, reversing 260,000 opioid overdoses. The money has come from taxpayers and parties to a nationwide settlement agreement with some other drug companies.

Last year, California lawmakers agreed to spend $30 million to partner with a pharmaceutical company to make its own version of naloxone. But they ended up not having to spend that money on that deal, since Amneal Pharmaceutical was already so far along in the FDA approval process that it didn’t need seed funding from the state.

Instead, California will use a portion of the revenue it receives from a national opioid settlement to buy the drugs.

Naloxone is just one drug Newsom’s administration is targeting.

Last year, California signed a 10-year deal with the nonprofit Civica to produce CalRx-branded insulin, which is used to treat diabetes. California has set aside $100 million for this project, with $50 million to develop the drugs and the rest to invest in a manufacturing facility. Newsom said a 10-milliliter vial of state-brand insulin would sell for $30.

Civica has met with the FDA and has a clear path forward, the Newsom administration said.

As we continue the effort to bring $30 insulin to market, the state is now willing to purchase life-saving naloxone at nearly half the current market price maximizing taxpayer dollars and saving more lives with this miracle drug, Newsom said in a statement. by his office