Dr. Reddy’s, Mylan Secure Approval for Suboxone Generic, Shares of Indivior Fall on the News

FDA Approval

Shares of Dr. Reddy's Laboratories Ltd. are surging this morning after the U.S. Food and Drug Administration (FDA) approved its generic version of Suboxone (buprenorphine and naloxone) sublingual film for opioid addiction.

With the approval of the combination treatment of buprenorphine and naloxone, India-based Dr. Reddy’s and co-developer Mylan NV are taking on British drugmaker Indivior, the manufacturer of Suboxone. The opioid-addiction drug generates about 80 percent of Indivior’s revenue. According to IMS Health, Suboxone generated $1.86 billion last year, Dr. Reddy’s said. Indivior had attempted to prevent Dr. Reddy’s from developing a generic to Suboxone by challenging it in court over patents, but the British company lost that legal battle. With the FDA approval of the Suboxone generic, shares of Indivior have plunged 28.17 percent on the London Stock Exchange.

Buprenorphine and naloxone are both used to treat adults who are dependent on or addicted to opioids. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs. Naloxone reverses and blocks the effect of opioids. Dr. Reddy’s said the combination of medications is” used as part of a complete treatment program including prescription monitoring, counseling and psychosocial support.”

Alok Sonig, Chief Executive Officer of Developed Markets for Dr. Reddy’s, touted the FDA approval of the company’s generic equivalent of Suboxone. Sonig said the approval comes at a critical time as the United States is in the grips of an opioid epidemic.

“We are excited to be launching this important product that will help enable patients to prevail over this insidious disease,” Sonig said in a statement. “This approval is an important milestone for our company and a testament to our commitment to bring affordable generic medicines to market for patients. Our company will continue to look for opportunities to acquire and manufacture assets that accelerate access to innovative and affordable medicines for patients.”

According to the U.S. Department of Health and Human Services, 116 Americans die daily from opioid overdoses. In 2016 there were an estimated 64,000 drug-related deaths in the United States, with the highest increase related to opioid drugs.

FDA Commissioner Scott Gottlieb also hailed the approval of the generic treatment. Gottlieb said the FDA is pushing for improved treatments for opioid use disorder and is also working to make sure the medications are available to those patients that need them. He said that also includes “facilitating market entry of generic versions of approved drugs to help ensure broader access.”

“The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction. Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren’t swapping one addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence,” Gottlieb said in a statement.

Subscription JPEG

Back to news