Court opens path for Dr. Reddy's to launch generic Suboxone
- The British pharma Indivior lost nearly half its market value Tuesday after a U.S. appeals court lifted a preliminary injunction that was preventing the sale of a generic version of an opioid treatment.
- Dr. Reddy's Laboratories, the India-based drugmaker, said the company would "resume its launch activities as soon as permitted" for its Suboxone generic in a Nov. 20 statement. Indivior expects a rapid loss of market share if the copy enters, potentially putting the company's revenue guidance in jeopardy.
- Suboxone makes up a majority of Indivior's revenue, and company stock fell about 45% Tuesday down to a share price of slightly above $7.
From a market perspective, the last six months have been difficult for Indivior. In early June, the British pharma was trading above $30 per share at a market company value of roughly $4 billion. Now, it's about one quarter of that size.
The drop started in June, when the Food and Drug Administration approved two generics for Suboxone (buprenorphine/naloxone) from Dr. Reddy's and Mylan. And while Mylan appears to be holding off for patent litigation to work itself out before jumping into the market, Dr. Reddy's launched at-risk shortly after getting regulatory approval.
On July 13, Indivior announced a U.S. district court in New Jersey had granted a preliminary injunction on the generic, in effect forcing Dr. Reddy's copy off the market. Even in that short window on the market, the generic competition eroded market share.
Indivior's market share hit a low of 50% in the third quarter, with the company squarely blaming Dr. Reddy's in its third quarter financial statement. Last year, it had averaged 58% market share.
Suboxone can treat both pain and addiction from opioids. This specific generic case centers around its film formulation, which is given under the tongue or inside the cheek in various dosage strengths.
Now, the turbulence to Indivior's market share on Suboxone is back. The U.S. Court of Appeals for the Federal Circuit issued a 2-1 ruling that vacated the preliminary injunction that held back Dr. Reddy's from market.
In the appeals court's reasoning, the judges stated Indivior had not demonstrated it was likely to succeed in a patent infringement case by its merits.
In a statement, Indivior's chief executive said he was "surprised and disappointed" by the ruling, but will "continue to vigorously pursue our infringement cases" against Dr. Reddy's to defend its Suboxone film patent portfolio.
In the meantime, Indivior will assume Dr. Reddy's will resume its launch, and such a launch would put the company's guidance figures, affirmed Nov. 1, at risk, the company said Nov. 21. The company is expecting net revenues for 2018 of between $990 million and just over $1 billion.
Exact timing of the expected launch isn't yet clear, as the appeals court still needs to issue a formal filing known as a mandate, Indivior said. The company plans to file a petition for a rehearing by the court.
"While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces challenges in the intervening period resulting from a potential material and rapid loss of market share to generic buprenorphine/naloxone sublingual film competition, including reduced earnings and cash flow," Indivior CEO Shaun Thaxter said in a statement.