Indivior launches authorized generic of its own Suboxone sublingual film
Indivior announced it has launched an authorized generic version of its Suboxone (buprenorphine and naloxone) sublingual film. The authorized generic is being marketed and distributed by Sandoz.
The company said it based its decision to launch an authorized generic on the market impact expected from the anticipated “at risk” launch of a generic buprenorphine and naloxone sublingual film product by Dr. Reddy’s Laboratories and/or Alvogen Pine Brook.
On Feb. 19, the Supreme Court denied Indivior’s motion to stay issuance of the U.S. Court of Appeals for the Federal Circuit’s mandate vacating a previously granted injunction granted against Dr. Reddy’s. The Court of Appeals for the Federal Circuit subsequently issued the mandate vacating the injunction against Dr. Reddy’s. The U.S. District Court for the District of New Jersey then issued orders dissolving the temporary restraining order against Alvogen and confirming the preliminary injunction against Dr. Reddy’s had been vacated.
“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," Indivior CEO Shaun Thaxter said.
The company said it based its decision to launch an authorized generic on the market impact expected from the anticipated “at risk” launch of a generic buprenorphine and naloxone sublingual film product by Dr. Reddy’s Laboratories and/or Alvogen Pine Brook.
On Feb. 19, the Supreme Court denied Indivior’s motion to stay issuance of the U.S. Court of Appeals for the Federal Circuit’s mandate vacating a previously granted injunction granted against Dr. Reddy’s. The Court of Appeals for the Federal Circuit subsequently issued the mandate vacating the injunction against Dr. Reddy’s. The U.S. District Court for the District of New Jersey then issued orders dissolving the temporary restraining order against Alvogen and confirming the preliminary injunction against Dr. Reddy’s had been vacated.
“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," Indivior CEO Shaun Thaxter said.