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BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received Food and Drug Administration approval for what the company said is one of the first generic versions of Suboxone sublingual tablets.
Amneal said Monday that buprenorphine HCl and naloxone HCl dihydrate sublingual tablets, for the maintenance treatment of opioid drug dependence, are now available in 2 mg/0.5 mg and 8 mg/2 mg dosages, both in 30-count bottles.
The product is bioequivalent to Reckitt Benckiser Healthcare’s Suboxone, according to Amneal.
"The FDA’s decision to approve the first generic equivalents to Suboxone sublingual tablets will ensure that millions of patients in the U.S. who need this product now have access to a high-quality, low-cost generic version," stated Chirag Patel, president and co-chairman of Amneal. "Since the agency has issued its opinion on Reckitt Benckiser’s September 2012 Citizen’s Petition in favor of generic competition, Amneal’s buprenorphine HCl and naloxone HCl tablets can offer consumers and physicians greater choice in opioid addiction treatment."
Annual U.S. sales of Suboxone in all dosage forms are $1.5 billion, according to IMS Health data cited by Amneal.
Amneal added that its product received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS), known as the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS program, and will be distributed in accordance with FDA and Drug Enforcement Administration regulations governing the handling of CIII controlled substances. The generic tablets will be available to patients when the BTOD REMS program becomes operational in early March, the company said.
