US top court deniesIndivior\'srequest on Suboxone;Dr Reddy\'s

US top court deniesIndivior'srequest on Suboxone;Dr Reddy's

Press Trust of India  |  Hyderabad 

Decks have been cleared for to launch the copycat version of Suboxone, a sublingual film, as the 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 in the US market.

"On February 19, the Supreme Court of the 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, Wednesday announced that its US affiliate, has launched an authorized generic version of (buprenorphine and naloxone) Sublingual Film in the US market.

On Indivior's behalf, markets the generic version.

In June last year, the (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.

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 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

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, February 20 2019. 15:45 IST