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Court of Appeals for the Federal Circuit lifts preliminary injunction on generic (buprenorphine and naloxone) sublingual film.- Indivior plc.

Read time: 1 mins
Last updated:22nd Jan 2018
Published:22nd Jan 2018
Source: Pharmawand

Indivior PLC announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) vacated the preliminary injunction (PI) previously granted against Dr. Reddy�s Laboratories (DRL) by the U.S. District Court for the District of New Jersey on 13 July 2018. The injunction had prevented DRL from selling, offering to sell, or import its generic buprenorphine/naloxone sublingual film product. In the absence of a PI, Indivior assumes that DRL will resume the launch of its generic buprenorphine/naloxone sublingual film product in the U.S. following the issuance of the mandate from the CAFC. Any DRL generic product sales in the U.S. would be on an �at-risk� basis, subject to the outcome of the appeal of the non-infringement judgments related to U.S. Patent Nos. 8,603,514 and 8,017,150, and ongoing litigation against DRL in the District of New Jersey asserting recently granted Orange Book-listed patents (including U.S. Patent No. 9,931,305).

The exact timing for DRL�s potential U.S. market re-entry is unknown, as the PI typically remains in effect until the issuance of a mandate by the CAFC (a formal filing by the CAFC that returns the case to the District Court for actions consistent with the CAFC�s ruling). Following today�s ruling vacating the PI, DRL filed a motion requesting that the CAFC either issue the mandate immediately or, alternatively, stay the PI pending issuance of the mandate. The Company will oppose DRL�s motion and file a petition for both panel rehearing and rehearing en banc of the ruling vacating the PI.

Indivior�s FY 2018 guidance for net revenue of $990-$1,020m and net income of $230-255m, which was issued on September 26th and confirmed on November 1st, was based on no material changes in current market conditions in the U.S. As such, the Company�s current FY 2018 guidance remains valid unless there is certainty of generic buprenorphine/naloxone sublingual film entry in 2018, in which case there would be risk to FY 2018 guidance. The magnitude of the risk will depend upon the timing of any generic entry. Should generic buprenorphine/naloxone sublingual film enter the market in 2018, the result would most likely be a rapid and material loss of market share for Suboxone (buprenorphine and naloxone) Sublingual Film.

Comment: Suboxone makes up a majority of Indivior's revenue, and company stock fell about 45% Tuesday down to a share price of slightly above $7.

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