Dr Reddy's re-launch generic version of Suboxone in US


Hyderabad, Feb 21 (IANS): With US Supreme Court ruling in its favour, Indian pharma major Dr. Reddy's Laboratories on Wednesday announced re-launch of generic version of Suboxone, a sublingual film for opioid addition treatment, in the US market.

Decks were cleared for the re-launch of Buprenorphine and Naloxone sublingual film after the US Supreme Court turned down UK pharma firm Indivior's plea against the launch of a copycat version of its Suboxone by competitors.

The United States Court of Appeals for the Federal Circuit concluded that Indivior had not shown that it is likely to succeed on its claim that Dr. Reddy's product infringes a US patent.

The decision vacates the District Court's preliminary injunction that had prohibited Dr. Reddy's from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film, the Hyderabad-headquartered company said in a statement.

As a result of the ruling, Dr. Reddy's has resumed shipping of the product.

"We are pleased with the decision of the appellate court in Dr. Reddy's favour, vacating the preliminary injunction that had prevented Dr. Reddy's from continuing to market this important drug to the public," said Marc Kikuchi, Chief Executive Officer, North America Generics.

"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," he said.

In June 2018, the US Food and Drug Administration (USFDA) approved Dr. Reddy's Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against Dr. Reddy's.

The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.

  

Top Stories


Leave a Comment

Title: Dr Reddy's re-launch generic version of Suboxone in US



You have 2000 characters left.

Disclaimer:

Please write your correct name and email address. Kindly do not post any personal, abusive, defamatory, infringing, obscene, indecent, discriminatory or unlawful or similar comments. Daijiworld.com will not be responsible for any defamatory message posted under this article.

Please note that sending false messages to insult, defame, intimidate, mislead or deceive people or to intentionally cause public disorder is punishable under law. It is obligatory on Daijiworld to provide the IP address and other details of senders of such comments, to the authority concerned upon request.

Hence, sending offensive comments using daijiworld will be purely at your own risk, and in no way will Daijiworld.com be held responsible.