FDA approves Amneal’s generic Suboxone to treat opioid drug dependence

Published on February 25, 2013 at 6:48 AM · No Comments

Amneal Pharmaceuticals, LLC, the 7th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone® sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles. The Amneal medication is bioequivalent to Suboxone® (a registered trademark of Reckitt Benckiser Healthcare (UK) Limited (LSE:RB)). Annual U.S. sales of Suboxone® in all dosage forms are $1.5 billion, according to December 2012 IMS Health market data.

Providing opioid-dependent patients with high quality generic buprenorphine HCl and naloxone HCl through treatment in physicians' offices, treatment centers, or prescriptions filled at retail pharmacies offers tremendous cost savings for both consumers and the U.S. healthcare system, while delivering the same therapeutic effect as the brand medication. To help their patients take advantage of this lower cost alternative, physicians should clearly indicate "buprenorphine HCl and naloxone HCl tablets" or "Suboxone® tablets" when writing prescriptions to avoid confusion at the pharmacy. Patients currently using any form of Suboxone® should ask their doctors or dispensing pharmacists for buprenorphine HCl and naloxone HCl sublingual tablets to get the cost-saving generic version with a pleasant orange flavor.

In addition to patients and their prescribing physicians, a more cost-effective opioid addiction treatment should be welcome news to insurance companies, the Centers for Medicare and Medicaid Services, the Veterans Health Administration and other payors, pharmacy benefits managers (PBMs), managed care facilities, drug addiction and recovery organizations and treatment advocacy groups as well. Generic drugs are saving the U.S. healthcare system one billion dollars every other day, according to the Generic Pharmaceutical Association.

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