Indian Supplier, Dr. Reddy’s, Wins Approval to Sell Anti-Opioid
One of the most popular and effective treatment tools for opioid addiction, Suboxone, is about to get much cheaper.
Dr. Reddy’s Laboratories, a leading Indian drug maker, announced in February that it had won a U.S. Court of Appeals fight to relaunch its buprenorphine and naloxone Sublingual Film, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States market. The court ruling vacated an injunction that kept the drug from being sold, and shipments of the drug resumed almost immediately.
Dr. Reddy’s equivalent is sold in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg doses.
The ruling means the generic will be available to the public nearly four years earlier than planned. Dr. Reddy’s had first won approval to sell the drug in the U.S. in 2018 before sales were halted by the injunction. In May, 2018, the company which makes Suboxone, Indivior, entered into a settlement agreement with several other drug makers which could have allowed them to sell generic versions of the drug beginning on Jan. 1, 2023.
Buprenorphine and naloxone, the generic names for Suboxone, mimic the effects of opioids but on a more measured basis, allowing opioid-addicted people to feel “normal” rather than high, explains buprenorphine-doctors.com. There is lower propensity for tolerance and doses can be tapered over time. When compared to methadone, buprenorphine has fewer respiratory effects and a reduced risk of overdose.
Suboxone Film is sold in thin foil packages which the user opens after drinking water to moisten the mouth. The film is absorbed by being placed under the tongue or inside the cheek. Chewing or swallowing the film or talking before it dissolves can dampen its effectiveness.
While effective, it’s not cheap. The National Institute on Drug Abuse recommends twice-a-day treatments; with pre-generics prices at $8.56 a dose, a monthly regimen could cost more than $500.
Dr. Reddy’s 8-milligram dose began selling for $6.33 after the court ruling, and Nitin Agarwal, an equity analyst who follows the generic industry for IDFC Securities in India, told Bloomberg that prices should eventually drop by 70 percent. The day after the court ruling, Indivior announced it had anticipated that the patent was at risk and would release its own Suboxone generic, which will be marketed and distributed by Sandoz.
With millions of Americans needing treatment for opioid abuse, Indivior had long experienced criticism over the cost of Suboxone, with The New York Times raising the issue back in 2013.
If generics won’t work in a user’s situation, there are other options for procuring Suboxone at lower prices, notes Drugabuse.com. Tactics include:
No matter the situation, confidential help is available. Call (888) 842-5501 to be connected with a participating treatment center to see what recovery options are available which may help your situation.