Data exclusivity

Special Condition Requests (conditional approval, accelerated review, additional year data exclusivity)... 

At the time the data exclusivity amendments were being discussed, the pharmaceutical industry sought to extend the provisions to protect data relating to new indications, new dosage forms or routes of administration, but was unsuccessful. 

The data exclusivity arrangements are primarily of interest to sponsors of products that are not otherwise protected by patent. A sponsor of a generic product may avoid the need for TG A to refer to protected information by submitting a full Category 1 application for registration, including preclinical and clinical data, although this would be unusual. 

In addition the EU law also allows for one year of additional data exclusivity for the whole compound if additional indications of significant overall therapeutic value are approved within the eight-year period (Towse 2004). 

TRIPS-plus provisions in FTAs regularly include limits on compulsory licensing prohibitions on parallel imports limiting market approval for generic drugs data exclusivity extended patent terms and evergreening" provisions. Since the U.S. often... 

ROYALTY TERM shall mean, with respect to each country in which Product is sold the period of time equal to the longer of (i) ten (10) years from the date of first sale of the Product in such country, (ii) the expiration of the last-to-expire Licensed Patent listed in EXHIBIT A in such country that claims such Product, or (iii) the period of time equal to the Data Exclusivity Period in such country. 

A registrant can use research data exclusively for 10 years unless another company agrees to pay the registrant reasonable compensation for its use. This is intended to protect the inventors of new pesticides and to promote innovation. 

Third-level headers to vary, depending upon available data exclusion of header to mean no relevant data available... 

The relevant data exclusivity periods for each approved drug product, as well as any applicable patents on the product or its use, are listed in the Orange Book , which is published by the FDA and also available electronically on the FDA s web site. 

Eighty-three patients provided concentration-time data. Exclusion criteria included elevated transaminases, bilirubin, or serum creatinine decreased neutrophils, hemoglobin, or platelet counts malabsorption syndrome opportunistic infections alcohol, narcotics, barbiturates, cocaine, or other CNS-active substance abuse hypersensitivity to any of the protocol mandated drugs patients of childbearing potential who were unwilling to use an effective method of contraception and concomitant medications interfering with human cytochrome P450 system. 

We shall not deal with the third law of thermodynamics at this point. The principal utility of the third law to the chemist is that it permits the calculation of equilibrium constants from calorimetric data (thermal data) exclusively. 

Model procedures Data exclusion Effect of data exclusion on outcomes Data invention Effect of data imputation... 

Grabowski H. Follow-on biologies data exclusivity and the balance betw een innovation and competition. Nature Reviews Drug Discovery 2008 7 479-488. 

The primary aim of this chapter is to describe the state of a mixture of gases and the changes in this state due to the chemical reactions which it is undergoing. A second aim is to suggest a way of working out the reaction schemes and the related kinetic laws it is an empirical approach, which can in principle be worked out on the basis of experimental data exclusively, and is independent of any mechanistic interpretation. 

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