Innovative drugs

While the tripartite countries of the more developed regions of the world have their own patent laws, and while they honor each other s property protection rights, some countries do not. Patent pirates in these countries freely copy (pirate) innovator drugs and drug products that are under patent protection in the United States and elsewhere without compensating patent holders. India is perhaps the worst pirate offender,... [Pg.816]

Often a particular market - antihypertensive drugs, for example - can include products of different types, such as generics and brand products, innovative and non-innovative drugs, and hospital and non-hospital ones, which further complicates their analysis.1... [Pg.87]

In other words, sol-gel entrapment technology provides innovative drug delivery solutions using sol gel based encapsulation systems in silica which enables new and stable combinations of APIs [active pharmaceutical ingredients] resulting in improved efficacy and usability . [Pg.178]

The priority review is applicable for orphan drugs, orphan medical devices and innovative drugs or medical devices that have been authorised to be highly necessary from a medical standpoint. The standards to define orphan drugs are the following (1) patient number of disease indicated for the drug concerned is less than 50 000 (2) excellent usefulness of the drug from the medical standpoint and (3) the development... [Pg.639]

In Chapter 4 Aidan Hollis examines three proposals in considerable detail. The first is an Advanced Purchase Commitment by sponsors, who offer an explicit subsidy in advance for innovative products. The subsidy offer includes a fixed-dollar amount per unit as well as a commitment to purchase a specific number of units at that price. The second proposal is that sponsors pay annual rewards based on the therapeutic effectiveness of innovative drugs. The third approach is to offer a patent extension on patented products to pharmaceutical companies if they successfully developed a vaccine for a disease such as HIV/AIDS that is highly prevalent, particularly in some low-income countries. Hollis concludes that the third approach is an extremely inefficient way to reward innovation. By contrast, the second approach could correct the market failure directly by rewarding innovative drugs according to their therapeutic effectiveness, which is measurable by cost-effectiveness analysis, a topic discussed later in greater detail in Chapters 10 and 11. [Pg.17]

The intertemporal (annual) and cross-sectional (therapeutic classes) variation in the cumulative number of drugs with NMEs allowed us to evaluate the contribution of pharmaceutical innovation to health outcomes empirically. Specifically, we explored whether greater improvements in health outcomes were realized for those diseases for which the stock of innovative drugs... [Pg.249]

A more balanced approach is to balance the added cost burden against the benefits of the new drugs. Because some health benefits accrue long after the added costs are incurred, there is admittedly a conflict between the time horizon of an elected official, which maybe from two to eight years, and the time horizon over which innovative drugs may have their full effects. [Pg.275]

CyDex, Innovative drug delivery technologies. www.captisol.com (accessed on 16 January 2003). [Pg.124]

Natural products represent an unparalleled source of molecular diversity for innovative drug discovery. In the pharmaceutical industry, there is an urgent need to identify novel lead structures for effective drug development in many therapeutic areas. It is likely that natural halogen compounds will continue to contribute leads to future research. [Pg.803]

It is important to note that generic drug products can be developed and approved more quickly than innovator drugs, because clinical trials are not typically required. A 505(b)(1) or 505(b)(2) NDA holder may delay approval of an ANDA due to patent or exclusivity considerations, however. These issues, however, while described briefly later, are beyond the scope of this chapter. [Pg.570]

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