Hours after the marketing protection on Subutex expired, generic equivalents entered the market. Currently we know of 3 companies that produce a generic buprenorphine (Subutex) product FDA approved for the treatment of opioid dependence (addiction). Prices for the generic mono-product (buprenorphine without the naloxone) still remain rather high at $3 - $7 per 8mg tablet. Brand name Subutex sublingual tablets were discontinued in 2011 in the US.
On February 25th 2013 the FDA approved the first two generic versions of Suboxone (Bup/Nx). These products reached pharmacy shelves in April. Prices between the brand name and generics are not substantially different yet. As more competitors enter the market the prices are expected to drop. Brand name Suboxone sublingual tablets were discontinued in 2012 in the US.
Sublingual tablets (Bup/Nx) - Orexo has increased the bio-availability when compared to buprenorphine film, accelerated dissolve time,
reduced tablet size and improved the taste. Two studies show that the subjects in the trials preferred Zubsolv over the competitors.
Important parameters are improved taste, mouth-feel and ease of administration. A New Drug Application for Zubsolv in the USA
was submitted to the FDA in September 2012. In November the FDA gave notice that the application had been accepted for review.
The decision date has been set for July 6, 2013. FDA approved 7/3/2013. (see press release)
UPDATE: Launched in September 2013, in pharmacies now.
Bio Delivery Sciences International- BUNAVAIL was FDA approved on 6/6/2014 and reached pharmacies in November 2014. - press release
Bio Delivery Sciences International- BEMA Buprenorphine is
currently in late stage clinical trials and is anticipated to be filed with the FDA for review in early 2015 and will seek the indication for pain.
On July 22, 2013 Canadian company IntelGenx Corp. announced it has filed an ANDA (Abbreviated New Drug Application -typically used for generic drug filings) with the FDA for a generic Bup/Nx film product. No details of the product as far as taste, packaging, or price. If approved, it could reach pharmacy shelves as soon as Q3 of 2014.
In August, 2013 IntelGenx learned that, in response to filing of the ANDA, it was named as a codefendant in a lawsuit filed by Reckitt Benckiser Pharmaceuticals and Monosol RX alleging infringement of U.S. Patents related to Suboxone®. IntelGenx is confident they will prevail. -company statement-
This novel delivery system implants buprenorphine rods under the skin with an in-office procedure. The rods produce a steady dose of buprenorphine
for six months. For patients with a history of low treatment compliance, or those who need to travel and can't get to a pharmacy monthly, this offers
a unique solution. But maybe the most significant attribute of this new delivery system is the elimination of the ritual of taking medication daily,
which can be a trigger or reminder of active painkiller addiction to many patients.
The FDA's final decision on approving Probuphine is expected April 30, 2013, and may show up in pharmacies as soon as July. UPDATE- FDA says NO! - see press release
UPDATE: meeting scheduled with FDA to discuss decision, November 19th 2013.
UPDATE: FDA demands further study - 1-2 year delay.
Reckitt Benckiser is predicting it will bring to market an injectable depot buprenorphine product that will last one month.
To suppress the debilitating symptoms of cravings and withdrawal, enabling the patient to engage in therapy, counseling and support, so they can implement positive long-term changes in their lives which develops into the new healthy patterns of behavior necessary to achieve sustained addiction remission. - explain -