Paragraph IV Notification

RNS Number : 2053B

Indivior PLC

05 October 2015

 

FOR IMMEDIATE RELEASE

INDIVIOR PLC

On 2 October 2015, Indivior Inc. ('Indivior') received a Paragraph IV notice of certification letter ('PIV Notice') from Sandoz Inc. ('Sandoz'), indicating that Sandoz has submitted an ANDA to the U.S. Food & Drug Administration ('FDA') seeking FDA approval to engage in the commercial manufacture, use and sale of a generic formulation of Indivior's 8mg/2mg Suboxone® sublingual film product.  Sandoz is the sixth ANDA filer to serve a PIV Notice on Indivior regarding Suboxone® sublingual film.

In its PIV Notice, Sandoz asserts that it is seeking approval of its ANDA before the expiration of Indivior's three Orange Book listed patents (U.S. Patent Nos. 8,017,150; 8,603,514; and 8,475,832) for Suboxone sublingual film, on the basis that these patents are not valid, enforceable and/or will not be infringed by Sandoz's generic product.

Indivior's Orange Book listed patents have expiration dates of February 13, 2023; April 3, 2024; and March 26, 2030. The Company intends to assert and enforce its intellectual property against Sandoz and will initiate a patent infringement lawsuit against Sandoz within 45-days of having received the PIV Notice, which will trigger the automatic stay of FDA approval of Sandoz's ANDA pursuant to the Hatch Waxman statute.

ENDS

Media Contacts

Stephen Malthouse                                     Jonathan Sibun

Tulchan Communications                           Tulchan Communications

[phone]                                        [phone]

[e-mail]              [e-mail]

Investor Contact

Tom Corran

Indivior, Director, Investor Relations

[phone]

 

END

 

 

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