US top court deniesIndivior’srequest on Suboxone;Dr Reddy’s gains

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)

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