INCLINE VILLAGE, N.V.,
June 5, 2017 /PRNewswire/
-- PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI)
today announced that its subsidiary, Noden Pharma DAC (Noden),
received a Paragraph IV Notice Letter advising that Anchen
Pharmaceuticals, Inc. (Anchen) submitted an Abbreviated New Drug
Application ("ANDA") to the United States Food and Drug
Administration (FDA) seeking authorization from the FDA to
manufacture and market a generic version of Tekturna ® aliskiren
hemifumarate tablets, 150 mg and 300 mg, in the United
States.
The Notice Letter contains certifications against U.S. Patent
No. 8,617,595, which is listed in the Approved Drug Products with
Therapeutic Equivalence Evaluations (the "Orange Book") for
Tekturna as expiring on February 19,
2026.
Noden is aware that Novartis received Paragraph IV
certifications from Par Pharmaceuticals, Inc. (Par) for Tekturna
HCT and Anchen on December 31,
2013. Novartis did not file a responsive patent infringement
suit related to these certifications. However, to Noden's
knowledge, neither Par nor Anchen have in the meantime
commercialized generic aliskiren products.
Noden intends to vigorously defend its intellectual property
rights related to Tekturna.
About Tekturna
Tekturna, also known as Rasilez outside
the U.S., is a high blood pressure medication. It is the only
product available in a class of high blood pressure drugs called
"direct renin inhibitors," which lowers blood pressure by blocking
the enzyme renin.
About Noden Pharma
Noden Pharma DAC is a global
specialty pharmaceutical company that is focused on acquiring
prescription medicines across a broad range of therapeutic areas in
international markets. The company focuses its resources on
acquiring and optimizing established medicines. Corporate
headquarters are located in Dublin,
Ireland.
About PDL BioPharma
PDL seeks to provide a significant
return for its shareholders by acquiring and managing a portfolio
of companies, products, royalty agreements and debt facilities in
the biotech, pharmaceutical and medical device industries. In
late 2012, PDL began providing alternative sources of capital
through royalty monetizations and debt facilities and in 2016,
began making equity investments in commercial stage companies, the
first being Noden Pharma DAC. PDL has committed
over $1.4 billion and funded approximately $1.1
billion in these investments to date. PDL is
headquartered in Incline Village, Nevada.
For more information, please visit www.pdl.com. PDL BioPharma
and the PDL BioPharma logo are considered trademarks of PDL
BioPharma, Inc.
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SOURCE PDL BioPharma, Inc.