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Your search for “patent exclusivity” returned the following results.
…on an overview of patent certifications and when an application may be eligible for final approval or tentative approval, as well as once a particular OGD review component (e.g., chemistry…
…patent settlement agreements, said that a top competition priority at the FTC is to stop such agreements. Mr. Liebowitz also revealed that “in the first nine months of FY 2010,…
…seasonal and and perennial allergic rhinitis covered by U.S. Patent No. 5,698,558 (“the ‘558 patent”) – XYZAL’s so-called “primary indications.” Earlier today, FDA responded. FDA denied the petition and approved…
…aspect on various product approval and patent and exclusivity issues. A list of all contributors is provided below. Quite a world class-group! Here’s a synopsis of the publication provided by…
…60 days before the expiration of a period of patent or non-patent market exclusivity applicable to the RLD or a 30-month stay blocking final ANDA approval. As we previously reported,…
…meet regularly to exchange information; Mutually recognize cGMP inspections; Allow manufacturers to make generic and biosimilar products during the periods of US patent term extension and EU Supplementary Protection Certificates,…
…The Agency goes on to argue that the recall ordered in the Hospira TRO could not even be requested by FDA because the basis for the recall was a patent…
…virtual “who’s who list” of FDA regulatory experts on myriad topics, including the approval process, pre-approval concerns, product labeling, clinical trials, adverse events reporting, and patent and non-patent marketing exclusivity…
…role in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, a Supreme Court decision in which the Court held that a patent use code qualifies as “patent information” submitted under FDC…
For generic drug companies, the biggest and most expensive challenge to a US product launch is the patent that covers the Active Pharmaceutical Ingredient (“API”). Notoriously, only one such patent…
…leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman…
…that was the first to seek entry prior to patent expiration for the relevant brand-name drug.” “From FY2004-FY2009, pharmaceutical companies filed a total of 218 final settlement agreements involving brand…
…patents listed were “sham patents” and that FTC never challenged the legitimacy of the patents. While the letter from Congress suggested nefarious motives for listing these patents, each company pointed…
…Exclusivity, Patent Prosecution, Litigation” scheduled for Thursday, February 13, 1:00pm-2:30pm EST. The panel will provide essential updates on FDA practice and patent law relating to biologics and biosimilars and discuss…
…not established economic injury due to complying with AB 824, which would require foregoing pay-for-delay settlements or litigating patent-infringement suits to judgment. The possible future injury is not enough to…