Following the acquisition of the ANDAs
, CASI plans to select and commercialise certain products from the portfolio that have unique market opportunity and cost-effective manufacturing in China and/or in the US.
The two states that have received an overwhelming majority of ANDA
filings are Delaware, with 911 cases filed since 2009 (up nearly 35% since 2014), and New Jersey, with 725 cases (up nearly 51% since 2014).
While the facts establishing specific personal jurisdiction in AstraZeneca are not easily replicated in most ANDA
litigations, which are often filed outside of the plaintiff's principal place of business, its holding is nonetheless a bellwether for the pharmaceutical industry.
Tracy has been a valued ANDA
financial executive and has the confidence of the management team, board of directors, and outside auditors," said Kenmore.
The report, which focuses on patent litigation related to Abbreviated New Drug Applications (ANDAs
) submitted to the FDA under the Hatch-Waxman Act, provides litigators with trends and data-driven insights from 2,646 ANDA
cases filed in US district courts between 1 January 2009 and 31 March 2017.
Two recent Federal Circuit cases address when a court should determine infringement by reference to the ANDA
specification alone, and when it must look to the physical product that is likely to be sold.
According to Jason Grenfell-Gardner, president and CEO, the company's team has filed five ANDAs
this week alone, including the ANDA
earlier today under a partnership with Impax Laboratories.
With two ANDAs
--for fluconazole tablets and carboplatin injection --currently under review at the FDA, at least three additional ANDAs
expected to be filed in the next four months and an additional 10 or more ANDAs
expected to be filed over the next two to three years, we believe we can achieve this goal.
Canada, Mexico and Latin America makes them the perfect partner for ANDA
," said Greg Gum, CMO of ANDA
Its 2014 goal of at least ten ANDA
submissions remains on track.
, EtherProbe, EtherView, EtherTone, EtherEdge, EtherReac, EtherStream, and EtherSlam are registered trademarks or trademarks of ANDA
M2 PHARMA-April 5, 2013-IGI Laboratories Inc submits its tenth ANDA
to the US FDA(C)2013 M2 COMMUNICATIONS