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)