Indivior launches generic version of its Suboxone opioid drug

[February 20, 2019]  By Pushkala Aripaka

(Reuters) - British drugmaker Indivior Plc said on Wednesday it had launched a copycat version of its blockbuster opioid addiction drug Suboxone in the United States, just one day after a court decision cleared the way for its rivals to market generic versions of it.

The U.S. Supreme Court ruling marked a victory for India-based generic drugmaker Dr. Reddy's Laboratories, which had earlier been blocked.

While launching generic versions of one's own treatments is not uncommon for drugmakers, it is pretty rare. In 2016, U.S. drugmaker Mylan NV floated the first generic version of its allergy auto-injector EpiPen after a backlash over the product's price.

Indivior said its launch of an authorized generic might prompt other companies to launch their own cheaper versions.

The company said in December that it might launch a cheaper version of Suboxone as part of a multi-phase contingency plan to stem market share losses from generic rivals. It said it expected revenue from its copycat in the tens of millions of dollars.
 

Indivior has spent over two years fighting multiple legal battles and patent disputes in the United States with companies including Dr. Reddy's, Teva and Mylan to block them from launching generics.

The drugmaker has said it faces potentially severe losses in market share to copycats in the immediate future.

It has pinned its hopes on its long-lasting opioid addiction Sublocade injection becoming another blockbuster and helping it reduce the dependence on Suboxone, which generates the bulk of its revenue.

The United States, which accounts for 80 percent of Indivior's revenue, faces an opioid abuse epidemic that President Donald Trump has declared a public health emergency, signaling a big opportunity for Indivior's newer opioid addiction treatments and Suboxone.

Indivior last week forecast Sublocade revenue for 2019 above analysts' expectations.

It is also looking to its schizophrenia drug Perseris as sales of Suboxone slow.

The company's shares have fallen nearly 80 percent since Dr. Reddy's and Mylan's generics were first approved by U.S. regulators in June 2018.

Jefferies analysts in a note said Indivior's launch was in line with expectations and that "most expect a significant and rapid erosion of Suboxone film's market share."

Indivior ended 2018 with a 53 percent share of the Suboxone film market in the United States, compared to 56 percent in 2017 and 61 percent in 2016.

The company's authorized generic is being marketed and distributed by Sandoz Inc.

(Reporting by Pushkala Aripaka in Bengaluru; editing by Bernard Orr and Jason Neely)

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