Brand-name Subutex tablets are no longer manufactured or sold. The product was discontinued by its maker and is listed in the FDA’s “Discontinued Drug Product List” in the Orange Book. However, the active ingredient in Subutex, buprenorphine, is still widely available as a generic medication and remains a standard treatment for opioid use disorder.
Why Subutex Was Discontinued
Subutex was a sublingual (under-the-tongue) tablet containing only buprenorphine, available in 2 mg and 8 mg doses. The manufacturer stopped producing the brand-name product, but not because of any safety concern or lack of effectiveness. The FDA formally confirmed this, noting that Subutex “was not withdrawn from sale for reasons of safety or effectiveness.” The discontinuation was a business decision, likely driven by the shift toward combination products like Suboxone, which pairs buprenorphine with naloxone to reduce the risk of misuse.
Because the FDA ruled the discontinuation wasn’t safety-related, generic versions of buprenorphine-only tablets were allowed to remain on the market and continue to be prescribed.
Generic Buprenorphine Is Still Prescribed
If your doctor previously prescribed Subutex, or if you’re looking for a buprenorphine-only product, generic buprenorphine sublingual tablets are available from multiple manufacturers. These contain the same active ingredient at the same doses. Pharmacies carry them routinely, and they are covered by most insurance plans and Medicaid.
You may also hear buprenorphine-only products referred to as “buprenorphine mono-product” or “monotherapy.” These are functionally identical to what Subutex was. The only difference is the brand name on the box.
Who Gets Buprenorphine Without Naloxone
Most people treated for opioid use disorder are prescribed the combination product (buprenorphine plus naloxone), because the added naloxone discourages misuse. If someone tries to inject the combination tablet instead of dissolving it under the tongue, the naloxone triggers withdrawal symptoms, which acts as a built-in deterrent.
Buprenorphine-only products are still preferred in specific situations. The most common is pregnancy. Both ACOG (the American College of Obstetricians and Gynecologists) and SAMHSA recommend buprenorphine as a first-line treatment for pregnant women with opioid use disorder, and the mono-product version is generally favored over the combination. The reason: naloxone exposure during pregnancy is not well studied, and if a pregnant person were to misuse the combination product, the naloxone could trigger withdrawal in both the mother and the developing baby. For this reason, clinicians typically prescribe buprenorphine alone during pregnancy and lactation.
Women who become pregnant while already taking the combination product are often transitioned to buprenorphine monotherapy for the duration of the pregnancy. Other less common reasons a provider might choose the mono-product include documented allergies or sensitivities to naloxone.
Other Forms of Buprenorphine Available Today
Beyond generic sublingual tablets, buprenorphine is now available in several other formats that didn’t exist when Subutex was first approved:
- Sublingual film: Thin strips that dissolve under the tongue, available as both combination (Suboxone) and buprenorphine-only products.
- Buccal film: A film placed against the inside of the cheek.
- Extended-release injection: A monthly injection given in a clinic, which eliminates the need for daily dosing.
- Subdermal implant: A small rod placed under the skin of the upper arm that delivers buprenorphine steadily for six months.
These newer delivery methods offer alternatives for people who have trouble with daily tablets or who want a longer-acting option. Your prescriber can help determine which format fits your treatment plan.
How to Get a Prescription
As of recent regulatory changes, any clinician with a standard DEA license can prescribe buprenorphine for opioid use disorder. The previous requirement for a special waiver (often called the “X-waiver”) was eliminated in 2023, which has made it significantly easier to find a prescriber. Primary care doctors, psychiatrists, and addiction medicine specialists can all write prescriptions for generic buprenorphine tablets.
If you previously took brand-name Subutex and are looking to restart treatment, a provider can prescribe generic buprenorphine sublingual tablets at the same dose you were on before. There is no clinical difference between the brand-name product and its generic equivalents.