25) Therefore, a generic manufacturer filing a section eight statement must request FDA approval to change the generic drug's labeling instructions to exclude the patented method of use listed in the Orange Book
That intention has led to abuse by originator firms because the FDA will not dispute the merits of any of the patents listed in the Orange Book
, no matter how weak the originator firms' claims may seem.
The Packeteer Orange Book
addresses multiple issues that enterprises face as they attempt to both accelerate and shape their network application traffic and ensure its secure delivery.
In conjunction, this will be the 12 US patent to be listed in the Orange Book
for VIMOVO, according to the company.
M2 PHARMA-May 26, 2016-Pernix Therapeutics awarded three new Orange Book
patents for Zohydro ER with BeadTek
M2 EQUITYBITES-October 15, 2015-Vanda reports inclusion of new Fanapt patent in the US FDA Orange Book
Dey's submission includes a Paragraph IV certification alleging that Sepracor's patents listed in the Orange Book
for XOPENEX(R) inhalation solution are invalid, unenforceable or not infringed by Dey's proposed product.
M2 EQUITYBITES-September 24, 2015-Vanda reports inclusion of new Fanapt patent in the US FDA Orange Book
The Company is currently in litigation with Shire in the United States District Court for the District of Delaware regarding Shire's claim that the Company's ANDA infringes the two Orange Book
listed patents, with a trial date scheduled for February, 2006.
M2 PHARMA-October 15, 2015-Vanda reports inclusion of new Fanapt patent in the US FDA Orange Book
This will be the twelfth US patent to be listed in the Orange Book
for PENNSAID two percent.
TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that the United States Food and Drug Administration (FDA) has confirmed - and has posted on its Orange Book
Web site - that Biovail's once-daily extended-release formulation of tramadol (Tramadol ER) has received three years of exclusivity, covering all dosages.