Update: Feb. 22, 2019: Mylan announced the U.S. launch of its generic version of Indivior's Suboxone, joining Dr. Reddy's on the market.
- Dr. Reddy's Laboratories is reintroducing its generic version of Suboxone sublingual film in the U.S. after a series of court victories over Indivior, the maker of the opioid dependence treatment.
- The U.S. Court of Appeals for the Federal Circuit in November found Indivior wasn't likely to succeed on a claim of patent infringement and ruled that a lower court's preliminary injunction stopping sales of the generic version should be lifted. Indivior then tried to block the appeals court ruling, ultimately taking the issue to the Supreme Court.
- Supreme Court Chief Justice John Roberts on Feb. 19 denied Indivior's motion to stay the appeals court mandate, in effect clearing the way to market for Dr. Reddy's as the litigation continues.
The stakes are high for Indivior. The company had sales of just over $1 billion last year, most of which came from Suboxone (buprenorphine and naloxone).
When Dr. Reddy's briefly put its generic on the market in June before the court issued a preliminary injunction, Indivior's market share fell to a low of 50%, after averaging 58% the year before. The company blamed competition from Dr. Reddy's version for the dip.
Indivior subsequently gained a preliminary injunction from a U.S. district court, preventing sales of the generic and allowing its market share to largely recover by year's end. Now, the generic threat has returned and looks likely to persist.
Indivior is attempting to mitigate the damage by introducing an authorized generic version of its own, which is being sold by Sandoz.
The authorized generic will carry a wholesale acquisition cost 14% below that of Indivior's branded version, a spokesperson for Sandoz confirmed in an emailed statement.
Indivior said in a Feb. 20 statement that it's possible other generic companies will jump into the market as well. The company also has another opioid-addiction treatment known as Sublocade (buprenorphine extended-release), which posted $12 million in sales last year.
Dr. Reddy's will be selling its version of Suboxone "at risk," meaning the company could be subject to damages if it ultimately loses the patent fight. Mylan, which along with Dr. Reddy's won FDA approval for its generic version of the medicine in June, announced the U.S. launch of its copy on Feb. 22.
Dr. Reddy's has already begun shipping its generic version, according to a Feb. 20 statement. The company noted that the original injunction didn't stop it from manufacturing the medicine.
The drug helps treat both pain and addiction to opioids. Patients put the film under the tongue or inside the cheek to release the medicine.