HYDERABAD, Feb 20: Decks have been cleared for
Dr Reddys Laboratories to launch the copycat version of
Suboxone, a sublingual film, as the US Supreme Court has
turned down UK pharma firm Indivior’s plea to stay a lower
courts order that paved the way for the launch.
Indivior is in legal battle against the launch of
copycat version of its opioid addiction treatment by
competitors including Dr Reddy’s Laboratories in the US
market.
“On February 19, the Supreme Court of the United States
denied Indivior’s motion to stay issuance of the US 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,” Indivior said in a regulatory filing.
Following the top Court order, Indivior PLC Wednesday
announced that its US affiliate, has launched an authorized
generic version of Suboxone (buprenorphine and naloxone)
Sublingual Film in the US market.
On Indivior’s behalf, Sandoz Inc markets the generic
version.
In June last year, the US Food and Drug Administration
(USFDA) approved Dr Reddys Buprenorphine and Naloxone
Sublingual Film, in four strengths including 2 mg/0.5 mg, 4
mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market.
The product was launched immediately after approval.
However, sales and commercialisation activities were
halted as a result of a court-imposed temporary restraining
order against Dr Reddys.
Suboxone had sales of around USD 1.86 billion in the US
for the 12 months ended April 2018, according to market
reports.
Indivior said any sale of Suboxone generic version sale
by Dr Reddys or Alvogen in the US will be on an “at-risk”
basis, subject to the outcome of the CAFC appeal of the
judgments related to some patent issues, as well as ongoing
litigation in the District of New Jersey. (PTI)