Dr Reddy’s re-launches generic version of Suboxone in US market


HYDERABAD, Feb 21 : Dr Reddy’s Laboratories Ltd. has said it re-launched its Buprenorphine and Naloxone Sublingual Film, generic version of Suboxone in the US market.

According to a press release issued by the city-based

drug maker Wednesdaynight, the re-launch comes on the heels

of a favourable decision delivered by the US Court of Appeals

for the Federal Circuitconcluding that UK-based Indivior had

not shown that it is likely to succeed on its claim that Dr

Reddy’s product infringes a patent pertaining to Suboxone.

Indivior is in a legal battle against the launch of

the copycat version of its opioid addiction treatment by

competitors including Dr Reddy’s Laboratories in the US


Suboxone had sales of aroundUSD 1.86 billion in the

US for the 12 months ended April2018, according to market


“We are pleased with the decision of the appellate

court in Dr Reddy’s favour, vacating the preliminary

injunction that had prevented Dr Reddy’s from continuing to

market this important drug to the public,” Marc Kikuchi, Chief

Executive Officer, North America Generics of DRL said.

In June 2018, the US Food and Drug Administration

(USFDA) approved Dr Reddy’s 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,

with sales and commercialisation activities halted as a result

of a court-imposed temporary restraining order (TRO) and

preliminary injunction against Dr Reddy’s.

The TRO and preliminary injunction did not prohibit

commercial manufacture of the product. (PTI)