The US court has cleared way for Dr. Reddy's Laboratories to launch generic version of Indivior’s Suboxone (buprenorphine and naloxone) sublingual film, which is an opioid addiction treatment.
The US Court of Appeals for the Federal Circuit (CAFC) has rejected Indivior’s motion to stay issuance of the mandate following its ruling vacating the preliminary injunction (PI) granted against Dr. Reddy’s Laboratories.
Based on the decision, Indivior has filed an emergency motion to stay the mandate pending resolution of its forthcoming application for an administrative stay to the Supreme Court of the US.
If granted, the stay would have permitted the Supreme Court time to resolve whether to administratively stay the CAFC mandate while it considered Indivior’s application to stay the mandate pending disposition of a petition.
The CAFC has rejected the motion on 11 February and ordered that the mandate issue on 19 February.
Indivior is also planning to lodge a petition to stay the mandate with the Supreme Court of the US.
Once the mandate is issued, Dr. Reddy’s and Alvogen Pine Brook cannot sell or import their generic buprenorphine/naloxone sublingual film product.
Both firms are planning to launch their generic buprenorphine/naloxone sublingual film in the US, after issuing the mandate by the CAFC
Suboxone film is a prescription medicine developed to treat of opioid dependence. It must be used under complete treatment, including counseling and psychosocial support.
Suboxone film is composed of buprenorphine, an opioid that can cause physical dependence with chronic use. It cannot be used for patients with severe hepatic impairment, and it has to be avoided for patients with moderate hepatic impairment.
Suboxone secured approval from the US Food and Drug Administration in August 2010.
Based in Richmond of Virginia, Indivior is a global specialty pharmaceutical firm engaged in the development of addiction treatments for alcohol use disorder, opioid overdose, and co-occurring disorders such as schizophrenia.
With more than 900 employees, the company markets its products in over 40 countries across the globe.