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 Dr. Reddy's and U.S.-based Mylan NV received approval from the Food
and Drug Administration (FDA) earlier this month to launch a generic
version of Suboxone Film, which generates 80 percent of Indivior's
revenue, forcing the UK company to file an injunction against the
decision.
Indivior said its temporary restraining order (TRO) issued on June
15 had been extended for another 14 days, during which time the U.S.
court for the District of New Jersey will consider the application
and issue a ruling on the injunction.
Shares of Indivior, which was spun out from Reckitt Benckiser in
2014, rose as much as 1.9 percent in early trading, but had edged
back to little changed by 0730 GMT.
Both Morgan Stanley and Jefferies analysts said the extension was a
positive, though the final ruling remained unpredictable.
The stock had lost about a third of its value after Dr. Reddy's said
earlier this month it would launch its new drug regardless of the
legal stand-off.
The company warned earlier that the Dr. Reddy's launch could result
in a rapid and material loss of U.S. market share for Suboxone Film,
which is placed under the tongue to suppress cravings.
The market share of the drug had declined to 55 percent by the end
of April from 60 percent last year, the British firm said last
month.
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Generic rivals in tablet form are already on the U.S. market, which
is grappling with an opioid addiction epidemic that killed 33,000
people in 2015.
Indivior said it would consider a potential launch of its own
generic product if Dr. Reddy's launched a copycat version.
Indivior's contingency plans would also focus on optimising the
launch of Sublocade, a once-a-month injectable drug to suppress
opioid craving launched in the United States in February. It
tempered expectations for initial sales of Sublocade at the launch,
saying it did not want investors to be unrealistic about its
prospects in its first year.
The company stuck to its 2018 revenue guidance despite Dr. Reddy's
getting the go-ahead for its product launch, but said it would
revisit the forecast if the move goes ahead.
Indivior is set to report first-half results on July 25. Jefferies
analysts said reassurance from the company on the progress of
Sublocade will be key to sentiment and share price support.
(Reporting By Justin George Varghese in Bengaluru; Editing by
Amrutha Gayathri and Jan Harvey)
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