(153) This act provides data
exclusivity for five years for
Until Depomed, orphan drug
exclusivity was automatic when the statutory criteria were met and if the FDA had not already approved and designated an orphan drug for the same use or indication.
Although the final TPP agreement fails to provide the 12 years of
exclusivity requested by the United States, the agreement nonetheless allows both the United States and Australia to essentially maintain the status quo.
The first clarification that Spencer discussed is that the timed
exclusivity would be with both the Xbox One and Xbox 360, which means that the game will come to both current and last-gen consoles.
This
exclusivity agreement gives us the confidence to know that we are doing something to make sure we stay relevant on the search engines and appear in the rankings of potential customers looking for a shredding service.”
Thanking Aridi for supporting MEA's bid to renew
exclusivity, Hout said 2012 had poised serious challenges to the flag carrier.
Emotionally, especially for nonprofit causes,
exclusivity competes well against greed.
But, we'll say it again: blackout rules, especially the national
exclusivity deal between FOX and MLB is some of the worst "consumer relations in favor of blatant profits" you're likely to ever find in all of consumerism.
The
exclusivity agreement maturity has been extended until November 30, 2011, from an earlier maturity date of October 11, 2011, for exploring developmental options of the properties.
* "Earning
Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act," by C.
The first proposal addresses data
exclusivity extension for innovative drugs.
(2) This 5-year period of
exclusivity is often referred to as a period of "data"
exclusivity, because it prevents FDA from approving an ANDA, which will necessarily rely on the data generated during the clinical trials for the reference product.
