REG - Indivior PLC - Paragraph IV Notification <Origin Href="QuoteRef">INDV.L</Origin>

IndiviorAnnouncement

05/10/2015 10:00

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 MalthouseJonathan Sibun
Tulchan CommunicationsTulchan Communications
+44 207 353 4200+44 207 353 4200
SMalthouse@tulchangroup.com JSibun@tulchangroup.com
Investor Contact
Tom Corran
Indivior, Director, Investor Relations
+44 1753 217800

This information is provided by RNS
The company news service from the London Stock Exchange
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