The National Alliance of Advocates
for Buprenorphine Treatment

Buprenorphine (Suboxone®, Subutex®3, Zubsolv®4, Bunavail™5, Probuphine®6) is an opioid medication used to treat opioid addiction in the privacy of a physician's office.1 Buprenorphine can be dispensed for take-home use, by prescription.1 This, in addition to the pharmacological and safety profile of buprenorphine, makes it an attractive treatment for patients addicted to opioids.2

Buprenorphine Pipeline

Timeline of buprenorphine products past, present, and future

buprenorphine pipeline graphic Orexo BDSI Titan Actavis Amneal RBP HiTechPharma RBP Purdue Teva Midlothian Roxane RBP DATA-2000 DATA-2000 RBP RBP Patent

September, 2013

Orexo receives FDA approval for Zubsolv® (buprenorphine/naloxone sublingual tablets) launched in September 2013

November, 2014

UPDATE: In pharmacies now 11/2014 - press release BioDelivery Sciences International, Inc. files NDA with the FDA for BUNAVAIL™ (Bup/Nx buccal soluble film) 7/31/13.

Probuphine delayed 1-2 years

Titan Pharmaceuticals, Inc. - 3/21/13 - FDA Advisory Committee recommends approval of Probuphine® (long-acting, subdermal buprenorphine implant)
UPDATE - April 30, 2013 FDA says NO!

February 25, 2013

Actavis receives FDA approval 2/0.5mg and 8/2mg sublingual buprenorphine/naloxone tablets (GnrBupNx2)

February 25, 2013

Amneal Pharmaceuticals receives FDA approval 2/0.5mg and 8/2mg sublingual buprenorphine/naloxone tablets (GnrBupNx1)

August 20, 2012

Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone® Film 4/1mg and 12/4mg (sublingual buprenorphine/naloxone)

September 24, 2010

Hi-Tech Pharmacal Co. receives FDA approval for sublingual buprenorphine tablet (GnrBup3)

August 31, 2010

Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone® Film 2/0.5mg and 8/4mg (sublingual buprenorphine/naloxone)

July 7, 2010

Perdue Pharma L.P. receives FDA approval for Butrans™ 7-day transdermal buprenorphine patch

May 25, 2010

Teva Pharmaceuticals USA Inc. receives FDA approval for sublingual buprenorphine tablet (GnrBup2)

November 1, 2009

Midlothian Laboratories receives FDA approval for sublingual buprenorphine tablet (GnrBup4)

October 8, 2009

Roxane Laboratories receives FDA approval for sublingual buprenorphine tablet (GnrBup1)

October 8, 2009

Reckitt Benckiser Pharmaceuticals Inc.'s Orphan Drug Marketing Exclusivity for Suboxone and Subutex expires

December 29, 2006

DATA-2000 amended to allow 100 patients per physician certified for more than one year

August 2, 2005

DATA-2000 amended to allow 30 patients per physician in group practices - instead of 30 per practice

October 8, 2002

Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone® (sublingual buprenorphine/ naloxone) and Subutex® (sublingual buprenorphine)

June 30, 1985

Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Buprenex™ (0.3 mg/ml IM injectable buprenorphine)

March 18, 1969

Patent #3,433,791 issued for buprenorphine

This page was last modified on : 11/09/2014

The Purpose of Buprenorphine Treatment:

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 -

The National Alliance of Advocates for Buprenorphine Treatment is a non-profit organization charged with the mission to:

  1. U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
  2. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.
  3. Subutex Discontinued in the US market in late 2011.
  4. Zubsolv (bup/nx sublingual tablet) FDA approved 7/3/2013 see buprenorphine pipeline graphic -in pharmacies now.
  5. Bunavail (bup/nx bucal film) FDA approved 6/6/2014 see buprenorphine pipeline graphic -in pharmacies now.
  6. Probuphine FDA approved 5/26/2016 - FDA Probuphine press release