For every patent listed in the Orange Book
that relates to the NDA-approved drug, the ANDA or section 505(b)(2) applicant must include appropriate patent certifications and explain the basis for its belief that the application does not infringe any valid claim of an Orange Book
What is more, if the originator firm lists another patent in the Orange Book
during the 30 months' stay, then it is entitled to file a new infringement lawsuit, automatically instigating a new 30-month stay and further extending its monopoly.
The commission has also found that, by timely listing of additional patents in the Orange Book
after a generic applicant has filed its abbreviated new drug application (ANDA), the brand-name companies can obtain additional 30 month stays of FDA approval of the generic applicant's ANDA -- thus extending the exclusive rights to market the branded formulation of the drug.
There are now two Orange Book
listed patents that cover NARCAN Nasal Spray.
This Orange Book
listing requires any Abbreviated New Drug Application (ANDA) applicant seeking FDA approval for a generic version of Vasostrict prior to expiration of the patent to notify Par Pharmaceutical of its ANDA filing before it can obtain FDA approval.
The Packeteer Orange Book
takes that advice one step further and offers users a way to see and then mitigate network attacks using PacketShapers, educating our customer base on how to recognize and remove threats from within their networks.
Several companies have unsuccessfully challenged one of these Orange Book
listed patents (US Patent No.
These '499, '982, and the '201 patents are a significant addition to the Orange Book
, bringing the total number of Orange Book
listed patents covering Zohydro ER with BeadTek to seven, said John Sedor, the company's chairman and interim CEO.
The FDA has informed Salix that the new marketing exclusivity expiration date for COLAZAL will be posted in the Electronic Orange Book
(EOB) at the EOB's next update.
Following issuance, Horizon and POZEN intend to list the patent in the US FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book
The statements contained in the letter are consistent with the FDA's Orange Book
and the FDA-approved labeling for BiDil and confirm that the FDA does not consider other drug products to be substitutable for BiDil.
Reddy's filed the ANDA for fexofenadine hydrochloride tablets 30 mg, 60 mg and 180 mg with a Para IV certification on all orange book