FDA approves Actavis’ generic Suboxone ANDA to treat opioid dependence

Published on February 26, 2013 at 12:52 AM · 3 Comments

Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone®.  

Actavis intends to begin shipping the product immediately.  Suboxone® is indicated for maintenance treatment of opioid dependence. 

For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data.

Source:

Actavis, Inc.

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Comments
  1. Jeff Tuttle Jeff Tuttle United States says:

    What took so long?? This should have been out years ago!! Suboxone went from $5.00 per pill when it first 4 years it came out to $10.00 today!! DOUBLE the price!!! Now Reckitt Benckiser wants some government protection on the Suboxone "Strip" claiming it is safer?
    There should have be SEVERAL generic versions of this drug by now!!!

  2. Jeff Tuttle Jeff Tuttle United States says:

    What took so long??
    This generic should have been out years ago!!
    Suboxone went from $5.00 per pill retail the first 4 years it came out to $10.00 today!! DOUBLE the price!!! Now Reckitt Benckiser wants some government protection on the Suboxone "Strip" claiming it is safer? BS!!
    There should have be SEVERAL generic versions of this drug by now!!! Someone needs to find out why this generic is just now becoming available!!
    The rise in price (double) is what caused this drug to become a "popular street drug" because of the PRICE!!

    • steven scott steven scott United States says:

      What caused this to just now become available as a generic? I would imagine it is because Reckitt Benckiser's patent on the drug ran out December 31, 2012, allowing other companies to manufacture the drug. I have been taking this for 7 years or so, and it has helped me. but as you said in the years the price has doubled and for the last 2 years the doctors have been hardcore pushing the original companies newish strips or film whatever.

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