Indivior PLC announced that its U.S. affiliate, Indivior Inc., has launched an authorized generic version of SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) in the U.S. The authorized generic is being marketed and distributed on Indivior’s behalf by Sandoz Inc.
This business decision is based on the market impact expected from the anticipated “at risk” launch of a generic buprenorphine and naloxone sublingual film product in the U.S. by Dr. Reddy’s Laboratories (“DRL”) and/or Alvogen Pine Brook LLC (“Alvogen”).
On February 19, the Supreme Court of the United States denied Indivior’s motion to stay issuance of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) mandate vacating the Preliminary Injunction (PI) granted against DRL. The CAFC subsequently issued the mandate vacating the PI granted against DRL. The U.S. District Court for the District of New Jersey then issued orders dissolving the temporary restraining order against Alvogen and confirming the PI against DRL had been vacated. DRL and Alvogen therefore are no longer prevented from selling, offering to sell, or importing their generic buprenorphine/naloxone sublingual film products.
Any DRL and Alvogen generic product sales in the U.S. will be on an “at-risk” basis, subject to the outcome of the CAFC appeal of the judgments related to U.S. Patent No. 8,603,514, (and U.S. 8,017,150 in the case of DRL), as well as ongoing litigation in the District of New Jersey asserting Orange Book-listed U.S. Patent Nos. 9,931,305 and 9,687,454.
Shaun Thaxter, Chief Executive Officer of Indivior, said,
We are making an authorized generic of our SUBOXONE® Film brand product available to patients and providers immediately, giving them yet another option of medication-assisted treatment for opioid dependence. In addition, we expect this launch will create the opportunity to maximize the value of our SUBOXONE® Film franchise.
With the launch of this authorized generic by Indivior, it is possible that other companies may also launch their own generic versions of SUBOXONE® Film.
As the current leading provider of buprenorphine medication-assisted treatment in the U.S., Indivior is committed to realizing its Vision that all patients around the world have access to evidence-based treatment for the chronic condition and co-occurring disorders of addiction.
SUBOXONE® Film is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.