The Core Misconception: Suboxone Isn't Gone, Its Form Has Changed
When patients and providers ask, "Why are they discontinuing Suboxone?", they are often referring to a specific event: the discontinuation of the brand-name tablet formulation by its manufacturer, then known as Reckitt Benckiser Pharmaceuticals (now Indivior). It is critical to understand that the medication for opioid use disorder (OUD), a combination of buprenorphine and naloxone, has not been discontinued. In fact, it remains widely available as the brand-name Suboxone Film and in various generic forms, including tablets and films.
A Strategic Discontinuation
On September 18, 2012, the manufacturer notified the FDA that it was voluntarily discontinuing the supply of Suboxone tablets in the United States. The company cited safety reasons, specifically concerns related to accidental pediatric exposure from multi-dose tablet bottles compared to individually wrapped films.
The Unofficial Market Rationale: Patent Expiration and Generic Competition
Alongside the public safety rationale, the discontinuation of the tablets coincided with the looming expiration of their patent and the expected market entry of generic versions. Critics and federal investigations alleged that the manufacturer's primary motivation was to move the market to its newer, patent-protected Suboxone Film before generic tablets could capture market share. This strategy faced legal challenges, resulting in significant settlements paid by Indivior.
Comparison: Tablets vs. Film vs. Generics
Patients today have multiple effective options for buprenorphine/naloxone treatment. The choice often comes down to cost, insurance coverage, and personal preference, as both films and tablets are considered clinically equivalent in efficacy.
| Feature | Brand-Name Suboxone Film | Generic Buprenorphine/Naloxone Tablets | Generic Buprenorphine/Naloxone Films |
|---|---|---|---|
| Form | Thin, dissolvable sublingual film | Sublingual tablets | Thin, dissolvable sublingual film |
| Manufacturer | Indivior | Various (e.g., Roxane, Akorn) | Various (e.g., Dr. Reddy's, Mylan, Alvogen) |
| Availability | Widely available | Widely available | Widely available, approved since 2018/2019 |
| Cost | Generally highest cost | Generally lower cost than brand-name film | Less expensive than brand-name film, competitive with generic tablets |
| Dosing | Various strengths available | Various strengths available | Various strengths available |
| Key Characteristic | Original patented film, individual packaging | The original form, now available as cost-effective generics | Cost-effective alternative to the brand-name film |
The State of Treatment Today
Buprenorphine/naloxone treatment is more accessible than ever due to the robust generic market for both tablets and films that emerged after the brand-name tablets were discontinued. While the FDA has noted the potential for dental injuries due to the acidity of buprenorphine, the benefits for treating OUD outweigh potential risks. Multiple effective and affordable formulations are available for patients and providers to choose from.
Conclusion
The discontinuation of brand-name Suboxone tablets was a strategic market shift by the manufacturer, driven by patent expiration and the rise of generic alternatives, rather than an end to the medication itself. This decision ultimately led to a broader market with more affordable generic options for buprenorphine/naloxone, which remains a cornerstone treatment for opioid use disorder. Patients continue to have access to effective treatment in various forms today.
Authoritative Link: For more information on buprenorphine, visit the Substance Abuse and Mental Health Services Administration (SAMHSA).
