Who makes Sublocade in the U.S?

Who makes Sublocade?

• Sublocade (buprenorphine) extended-release injection is made by Indivior Inc. Contact information for Indivior Inc. can be found here. To contact Indivior by phone in the U.S. and Canada call 1-877-782-6966.
• Sublocade is a long-acting, once-monthly subcutaneous (given under the skin) injection that steadily releases buprenorphine into your bloodstream for the treatment of opiate dependence (opioid use disorder).
• Sublocade is only given by a healthcare provider. Serious harm or death could result if administered intravenously. Your doctor will order Sublocade for you and also administer it each month.

Sublocade is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal). It is part of a complete treatment regimen that should include counseling. It is classified as a partial opioid agonist.

Sublocade is a long-acting subcutaneous (under the skin) injection given once-a-month to treat moderate to severe opioid dependence along with counseling and social support. It is used in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

View detailed dosing instructions for Sublocade here.

When was Sublocade approved by the FDA?

Sublocade was approved by the FDA in November 2017. Sublocade was the first once-monthly injectable buprenorphine product for opioid use disorder (OUD) in adults who have initiated treatment with a transmucosal (absorbed via mucus membrane) buprenorphine-containing product.

In studies, Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use compared to a placebo group.

Related: Sublocade FDA approval history

Where can I get Sublocade?

Sublocade is only available through a restricted program called the Sublocade REMS Program due to risk of harm or death due to intravenous self-administration. Your doctor will order this medicine for you, and you will receive it a clinic or doctor's office.

Healthcare settings and specialty pharmacies that order and dispense Sublocade must be certified in this program and comply with the REMS requirements.

Sublocade is not available in your regular, local retail pharmacies. It is a long-acting injection given by a healthcare provider and is classified as a CIII controlled substance in the U.S.

Patients can contact InSupport, a program from Indivior, to learn more about Sublocade, your health insurance benefits, possible financial assistance, and local treatment providers.

You can call InSupport at 1-844-INSPPRT or access their website here. Your doctor can also provide you a from to fill out to start the enrollment process. If you would like help finding a healthcare provider for opioid use disorder, you can call: 1-877-782-6966

Related questions

• What are the different brands of buprenorphine?
• Is buprenorphine an opiate / narcotic?
• What is the difference between Sublocade and Brixadi?

How is Sublocade given?

Your doctor or other healthcare provider will give you Sublocade as a subcutaneous injection (under the skin). You will usually receive this in your doctor’s office. Subclocade is typically given once a month (with at least 26 days between doses).

Sublocade can be administered subcutaneously in the abdomen (stomach area), thigh, buttock, or back of the upper arm.

Sublocade changes to a solid form called a depot after injection. Your medicine will slowly release from this depot. After injection, you may feel a small bump under your skin. Do not try to remove the depot, rub or massage the injection area. Do not let tight clothes, belts or waistbands rub against the injection site.

In February 2025, key changes were made to the Sublocade label:

• Rapid initiation Protocol: Healthcare providers can now initiate treatment with Sublocade after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.
• Alternative Injection Sites: Sublocade can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.

This is not all the information you need to know about Sublocade for safe and effective use and does not replace your healthcare provider's directions. Review the full product information, and discuss this information and any questions you have with your doctor or other health care provider.