Is There a Generic Form of Sublocade for Opioid Use Disorder?

October 10, 2025 •

4 min read

In 2023, nearly 80,000 overdose deaths in the U.S. involved opioids [1.8.5]. For those seeking treatment for opioid use disorder (OUD), a key question is: is there a generic form of Sublocade? Currently, the answer is no [1.2.1].

Quick Summary

As of late 2025, no generic equivalent for the brand-name medication Sublocade is available in the United States. Patent protections and manufacturing complexity are key reasons for its absence.

Key Points

No Generic Available: As of late 2025, there is no FDA-approved generic version of Sublocade in the United States [1.2.1].
Patent Protection: Sublocade is protected by multiple patents, with the earliest expiring in 2031 and others extending to 2038, preventing generic competition [1.3.1, 1.3.4].
Manufacturing Complexity: Sublocade is a complex injectable that is difficult to replicate, posing a significant challenge for generic drug makers [1.9.2, 1.9.3].
Primary Alternative: Brixadi is another brand-name, long-acting buprenorphine injection that offers more dosing flexibility with weekly and monthly options [1.5.2].
Cost-Effective Options: Daily oral medications like generic Suboxone (buprenorphine/naloxone) films and tablets are widely available and generally more affordable [1.2.2, 1.7.3].
Different Mechanism: Vivitrol (naltrexone) is a monthly injectable alternative that works by blocking opioid receptors, rather than partially activating them [1.6.3].
Prerequisite for Use: To start Sublocade, a patient must first be stabilized on a daily oral buprenorphine product for at least seven days [1.2.2].

Understanding Sublocade and Its Role in OUD Treatment

Sublocade is a brand-name prescription medication approved by the FDA on November 30, 2017, for the treatment of moderate to severe opioid use disorder (OUD) in adults [1.4.4, 1.2.6]. It contains the active ingredient buprenorphine, which is a partial opioid agonist. This means it binds to and activates the same opioid receptors in the brain that drugs like heroin or fentanyl do, but to a much lesser degree [1.5.1]. The result is a reduction in withdrawal symptoms and cravings without producing the euphoric high associated with opioid misuse [1.6.4].

What makes Sublocade distinct is its formulation as a long-acting, extended-release injection. It is administered by a healthcare professional once a month via a subcutaneous (under the skin) injection in the abdomen [1.2.2]. After injection, the liquid medication forms a solid depot, which slowly releases a steady dose of buprenorphine into the bloodstream over the entire month [1.5.6]. This consistent medication level helps maintain stability for patients, removing the need for daily dosing and reducing the risks of missed doses or medication diversion [1.6.4]. Treatment with Sublocade is initiated only after a patient has been stabilized on a transmucosal (dissolving in the mouth) buprenorphine product for at least seven days [1.2.2].

Why No Generic Sublocade is Available

The primary reason for the absence of a generic Sublocade is robust patent protection. The manufacturer, Indivior, holds multiple patents covering various aspects of the drug, including its formulation, dosing regimens, and method of administration [1.3.1]. The earliest of these patents are not set to expire until 2031, with others extending as far as 2038 [1.3.1, 1.3.4]. This means other pharmaceutical companies are legally prevented from manufacturing and selling a generic version until these patents expire or are successfully challenged in court.

Beyond the legal barriers, developing a generic equivalent to a long-acting injectable like Sublocade presents significant scientific and technical hurdles. These are known as "complex generics" [1.9.3].

Challenges include:

Complex Formulation: The drug uses a specific delivery system (the Atrigel Delivery System) to create the solid depot in the body. Replicating this technology precisely to ensure the same rate and duration of drug release is incredibly difficult [1.4.1, 1.9.2].
Manufacturing Complexity: The manufacturing process for complex injectables is more intricate and requires specialized equipment and expertise compared to standard oral tablets [1.9.2].
Regulatory Hurdles: Proving bioequivalence to the FDA is more challenging than with simpler drugs. A generic manufacturer must demonstrate that their product releases the active ingredient into the bloodstream at the same rate and to the same extent as Sublocade, which is a high bar for such a complex formulation [1.9.3].

Alternatives to Sublocade

While a generic for Sublocade is not available, patients and healthcare providers have several other effective medication-assisted treatment (MAT) options for OUD. The choice depends on factors like the patient's medical history, lifestyle, and treatment goals [1.6.5].

Injectable Buprenorphine Alternatives

The closest alternative to Sublocade is Brixadi. Approved in May 2023, Brixadi is also an extended-release buprenorphine injection [1.5.4]. However, it offers more flexibility. Brixadi is available in both weekly and monthly dosing options, and it can be injected in the buttock, thigh, upper arm, or abdomen [1.6.6, 1.5.1]. This allows for more personalized treatment plans, especially for patients who may benefit from more frequent dose adjustments [1.5.3]. Like Sublocade, Brixadi is also a brand-name drug with no generic version currently available [1.4.2].

Other Buprenorphine Formulations

Daily-dose formulations of buprenorphine are widely available and often more affordable, as many have generic versions [1.2.2].

Suboxone: This is a combination of buprenorphine and naloxone, available as a sublingual film or tablet taken once daily [1.6.4]. The naloxone is included to deter misuse; if the film is dissolved and injected, the naloxone will cause immediate and severe opioid withdrawal symptoms [1.2.2]. Generic versions of Suboxone are available, making it a more affordable option for many [1.6.1].
Zubsolv/Bunavail: These are other brand-name combinations of buprenorphine and naloxone with different absorption characteristics.
Generic Buprenorphine/Naloxone: These sublingual tablets offer the most cost-effective option for daily buprenorphine treatment [1.7.3].

Other Classes of OUD Medication

Vivitrol: This is a monthly injection of naltrexone, an opioid antagonist. Instead of partially activating opioid receptors, Vivitrol blocks them completely, preventing any opioid from having an effect [1.6.3]. It is used to prevent relapse in patients who have already detoxed from opioids [1.4.2]. There is no generic version of Vivitrol [1.4.2].
Methadone: A long-acting full opioid agonist, methadone is dispensed daily at federally regulated clinics. It reduces cravings and withdrawal symptoms [1.2.4].

Comparison of Sublocade and Its Alternatives


Medication	Active Ingredient(s)	Administration	Dosing Frequency	Generic Available?
Sublocade	Buprenorphine	Subcutaneous Injection	Monthly	No [1.2.1]
Brixadi	Buprenorphine	Subcutaneous Injection	Weekly or Monthly	No [1.6.2]
Suboxone	Buprenorphine/Naloxone	Sublingual/Buccal Film	Daily	Yes [1.2.2]
Vivitrol	Naltrexone	Intramuscular Injection	Monthly	No [1.4.2]
Methadone	Methadone	Oral Liquid/Tablet	Daily	Yes

Conclusion

As of September 2025, there is no generic form of Sublocade available in the United States due to long-standing patents and the high complexity of its manufacturing process [1.2.1, 1.3.1]. Patients seeking a long-acting buprenorphine injection have a similar brand-name alternative in Brixadi, which offers more dosing flexibility [1.5.2]. For those seeking more affordable or different types of treatment, generic daily buprenorphine/naloxone tablets and films, as well as other medications like Vivitrol and methadone, are established and effective options for managing opioid use disorder [1.6.1, 1.6.3]. The decision on which medication to use should always be made in consultation with a qualified healthcare provider who can assess the patient's individual needs and circumstances.

Authoritative Link: For more information on buprenorphine treatment, visit the Substance Abuse and Mental Health Services Administration (SAMHSA).

Frequently Asked Questions

No, as of September 2025, there is no generic version of Sublocade available in the U.S. It remains a brand-name-only medication [1.2.1].

A generic version of Sublocade is not available due to a combination of factors. The primary reason is that the drug is protected by numerous patents that extend into the 2030s [1.3.1]. Additionally, its complex, long-acting injectable formulation is technically difficult and expensive for generic manufacturers to reproduce and prove bioequivalence [1.9.3].

Sublocade is protected by a number of patents. While some have expiration dates as early as 2031, others extend until 2035 and 2038, meaning a generic version is not expected for several years [1.3.1, 1.3.4].

The closest alternative is Brixadi, another brand-name buprenorphine injection. It differs by offering both weekly and monthly dosing options, providing more flexibility in treatment compared to Sublocade's monthly-only schedule [1.5.2, 1.5.3].

No. While both contain buprenorphine, Sublocade is a once-monthly injection administered by a healthcare provider. Suboxone is a daily film or tablet that dissolves in the mouth and also contains naloxone to deter misuse [1.6.4]. Generic versions of Suboxone are available, while Sublocade has no generic [1.2.2].

Sublocade is significantly more expensive. Without insurance, Sublocade can cost over $1,900 per monthly injection [1.7.2]. In contrast, generic daily buprenorphine/naloxone (like Suboxone) can cost between $100 and $600 per month [1.7.5].

Yes, switching is a common treatment path. A patient must first take a stable dose of an oral buprenorphine product (like Suboxone) for at least 7 days before starting Sublocade injections to ensure they tolerate the medication well [1.2.2].