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Providing straightforward information pertaining to drugs, drug use & drug policy. The Grey Pages promotes drug-related literacy and advocates a system of viable and tolerant drug policies. This is my personal collection of commentaries, essays, tid-bits, and other such writings on everything ranging from drug use, drug policy and drug-myths, to drug-science, addiction, human behavior, and the workings of the human brain. I started this blog with a particular focus on opioids, and over the past year have found my interest gravitate toward the intriguing, ever-changing world of designer intoxicants (i.e. "research chemicals" or "designer drugs").

Saturday, March 2, 2013

Generic Suboxone? What happened?

For roughly 4 years we've awaited a generic version of Suboxone to become available. 

However, by the time the patent expired on the original Suboxone tablets, Reckitt Benckiser (its manufacturer) had aquired an exclusive new patent, on an exclusive, new form of their product. Their new product was Suboxone film; the same medication, only rather than in tablet form, it came in the form of paper-thin film strips, each enclosed in a plastic wrapper.

Around the same time, in order to avoid generic competitors from introducing a cheaper suboxone tablet to the market, RB took some bold measures; first, they convinced private insurers that their former tablet formulation of Suboxone was unsafe, and emphasized the possibility of the tablet being consumed by young children. 

They introduced the "new and improved" formulation; film strips, each individually wrapped in a child-proof container. RB convinced many insurers that they should no longer provide coverage for the tablet formulation (or at least not without the doctor justifying, in writing, why the tablet form was nessessarry), and that they should exclusively cover the new, patent-protected film formulation, which only their company could produce.

Insurance providers bought it. Subsequently, the manufacture and marketing of a generic suboxone became unappealling, due to the limited profits it would produce (remember, RB convinced many insurers to only cover the new version of the drug). This bought some time, and further delayed the possibility of a generic being introduced to the market. 

Roughly 3 years later, RB sent a CITIZENS PETITION to the FDA claiming that its original product (the tablets) was a "bad drug", and requesting that a ban be placed on its manufacture and sale, in order to "protect the public" from their previous tablet formulation. 

Had the FDA granted this request, all generic manufacturers would have been prevented from ever introducing a generic suboxone tablet (a prospect which, until that point, would have been inevitable). RB would have been left to dominate the market, with an overpriced and overhyped, patent protected, suboxone film.

However, in recent days, the FDA denied Reckitt's petition. Long story short; the door remains open for a generic product to be made available. When or if this will happen is another question - though it's quite likely  to happen in the near future, as RB has as of mid-march discontinued the tablet formulation of suboxone. In the meantime, the film is available in two new dosages; one containing 4 mg buprenorphine, and another containing 12 mg buprenorphine.

Read more here


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