Is There A Generic Suboxone Film?
As many people already know, Suboxone comes in many different forms and strengths although the active ingredient in all forms is Buprenorphine. The majority of the formulations are sublingual which means you take them by placing them under your tongue and letting the Buprenorphine dissolve completely although Bunavail is a buccal formulation (placed against the side of your cheek) and there are also newer injectable forms such as Sublocade that are given as a subcutaneous shot that goes into your stomach and releases a steady amount of Buprenorphine over a month's period.
More About The Term Suboxone
The term "Suboxone" generally refers to the brand name version which only comes as a film in the 2-0.5 mg, 4-1 mg, 8-2 mg, and 12-3 mg dosage. There used to be a brand name Suboxone tablet made by Reckitt Benckiser (now Indivior) which is the same company that makes the Suboxone film but these were discontinued in 2012 due to an increased risk of accidental exposure to the pediatric population. Sometimes the term "Suboxone" is still used today to describe the generic Buprenorphine-naloxone tablet which only comes in the 2-0.5 mg and 8-2 mg dosage. Since the tablet form is generic it is generally much cheaper than the brand name Suboxone film so many insurance companies including most Medicaid programs will only cover the cheaper Buprenorphine-naloxone tablet. This creates an issue for many patients who have some form of intolerance to the tablet and are dependent on the Suboxone film for their needs. It also can be an issue for those patients trying to taper since the tablet form is much harder to cut into small pieces whereas the film is much easier.
Then in mid 2018 the FDA came out with an announcement that they approved the first generic version of the Suboxone film to be developed for the treatment of opioid dependence. The company given approval to market the first generic films were Mylan Technologies Inc. and Dr. Reddy's Laboratories SA. This was great news for many patients who were being crippled by the horrible side effects of the generic Buprenorphine-naloxone tablets that they were being forced to take as a result of their insurance coverage. However, this victory was short-lived as Indivior (the makers of the brand name Suboxone film) filed a temporary restraining order against Dr. Reddy’s Laboratories Ltd a month later in July preventing them from further creating, marketing, or selling its generic version of the Suboxone film pending final litigation.
The Saga Continues
The preliminary injunction was rejected by an appeals court in November 2018 allowing India’s Dr. Reddy’s Laboratories to resume marketing and manufacturing of its generic Suboxone film. However, Indivior was successful in issuing a petition to stay the preliminary injunction in December 2018 again halting Dr. Reddy’s Laboratories for now. Indivior also put out a statement to it's investors that it plans to launch its own version of a Suboxone generic film in the event that a competitor is successful in bringing one to market. So as of now a true generic Suboxone film does not exist although will likely be available in the near future. In the meantime, patients are the ones that are suffering the consequences.