The generic firm can also claim that, though the Orange Book
lists an unexpired patent for a competing drug, the patent is either invalid or will not be infringed by the generic.
Mr German urged the party's leadership to listen to grassroots supporters rather than those in a "rarefied policy atmosphere" who developed the Orange Book
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.
The FDA's Orange Book
was first published in 1980 to respond to requests from states for a list of approved and therapeutically equivalent drugs to help make choices that can reduce drug costs.
EvaluatePharma, the premier source for life science sector analysis and consensus forecasts, today launched a new service enhancement, Tracking Drugs@FDA, which gives clients access to the entire universe of approved FDA drugs and the related FDA document library as well as FDA Orange Book
patent data - all fully integrated into the industry-leading EvaluatePharma platform and analytical tools.
Our IP estate around Gralise is considerable, now with seven Orange Book
listed patents providing protection into 2024, numerous defensive patents covering alternative formulation approaches and several additional applications in active prosecution.
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.
The patent has been listed for LUVOX CR(R) in the FDA Orange Book
Breath Limited'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 Breath Limited's proposed product.
5,344,658 (the "'658 patent"), one of the patents listed in the FDA's Orange Book
as covering the Zofran(R) brand of ondansetron hydrochloride tablets.
In connection with the FDA's acceptance for filing of the ZEGERID Chewable Tablets NDA, Santarus provided notice to the NDA holder for Prilosec(R) delayed-release omeprazole capsules and related patent holders that ZEGERID Chewable Tablets 40 mg and 20 mg do not infringe the patents listed in the Orange Book
for Prilosec or that those patents are invalid.
This release contains forward-looking statements, which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the Company's plans to pursue its administrative and legal remedies in response to the FDA's decision to allow ANDA applicants to delete the use listed in the Orange Book
for the 128 Patent from their product labeling.