Generic Therapies Available for Treating Opioid Dependence

Two generic buprenorphine and naloxone sublingual film products are on the market for treating opioid dependence, following a new approval from the FDA and patent litigation.

The therapies, from Mylan and Dr. Reddy’s Laboratories, are generic equivalents of Indivior PLC’s Suboxone sublingual film.^1,2

FDA officials approved both generic versions of buprenorphine and naloxone sublingual film in June 2018.

They were the first generic versions if Indivior’s product, according to the agency.³

“When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence,” FDA Commission Scott Gottlieb, MD, said in a statement.³

“Patients addicted to opioids who are eventually treated for that addiction and successfully transition onto medicines like buprenorphine aren’t swapping 1 addiction for another, as is sometimes unfortunately said," he said. "They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids.”

Dr. Reddy’s Laboratories’ buprenorphine and naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg product was initially launched immediately following its FDA approval. However, sales and commercialization activities were halted, because of a legal challenge concerning Indivior’s patent.

According to Dr. Reddy’s Laboratories, its generic product resumed shipping this week, following a decision in the company’s favor by the United States Court of Appeals for the Federal Circuit.¹

“We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from continuing to market this important drug to the public,” Marc Kikuchi, chief executive officer of North America Generics, said in a statement.¹

“Dr. Reddy’s is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the United States who are impacted by the opioid epidemic," Kikuchi said.

Mylan also said that it is launching its buprenorphine and naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg product, following final FDA approval for the treatment’s abbreviated new drug application.

The prescription product should be used as part of a complete opioid dependence treatment plan that includes counseling and psychosocial support, according to Mylan.²

Adverse effects commonly observed with the buprenorphine and naloxone sublingual film are accumulation of fluid causing swelling in lower limbs, burning mouth, constipation, excessive sweating, headache, inflammation of oral mucous membrane, insomnia, nausea, oral numbness, pain, signs and symptoms of withdrawal, and vomiting, according to the FDA.³

Generic drugs approved by the FDA have, among other things, the same quality as brand name drugs, according to the agency.

Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand name drugs.³

FDA Approves First Generic of Drug Used to Treat Opioid Dependence

References

• Dr. Reddy's Laboratories announces the re-launch of its buprenorphine and naloxone Sublingual Film after favorable ruling in patent litigation [news release]. Hyderabad, India, and Princeton, New Jersey; February 20, 2019; Dr. Reddy's Laboratories. businesswire.com/news/home/20190220005717/en/Dr.-Reddys-Laboratories-Announces-Re-Launch-Buprenorphine-Naloxone. Accessed February 22, 2019.
• Mylan launches generic Suboxone Sublingual Film to treat opioid dependence [news release]. Hertfortshire, England, and Pittsburgh, Pennsylvania; February 22, 2019: Mylan. investor.mylan.com/news-releases/news-release-details/mylan-launches-generic-suboxoner-sublingual-film-treat-opioid. Accessed February 22, 2019.
• FDA approves first generic versions of Suboxone Sublingual film, which may increase access to treatment for opioid dependence [news release]. Silver Spring, MD: June 14, 2018; FDA website. www.fda.gov/newsevents/newsroom/pressannouncements/ucm610807.htm. Accessed February 22, 2018.