Patented drugs market

Conk, G.W., "The True Test Alternative Safer Designs for Drugs and Medical Devices in a Patent-Constrained Market," UCLA L. Rev., 49, 737 (1990). 

The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. The study does not address other procedures for generic entry, and it does not address the patent restoration features of Hatch-Waxman. 

Although they obtained patents on the use of MDA for these applications (and also as a weight-loss product), they never developed commercial products from the compound. The problem, which appeared during human trials, was that the psychic effects on subjects were too severe to permit use of MDA for its intended functions. The compound caused overstimulation of the CNS, which sometimes resulted in panic attacks among subjects. This drawback did not, however, prevent the spread of MDA in the illicit drug market, where it eventually became one of the most popular substances used in the 1960s, when it was widely known as "the love drug. ... 

Herbal remedies currently are considered dietary supplements and, hence, are regulated under the same provisions as foods. Thus, to be marketed, these products do not have to meet the same stringent manufacturing or testing requirements as do patented drugs. The net result is twofold ... 

Based on the examples provided above and the many successful applications of isosterism in the design of safer drugs and pesticides, it appears that isosteric replacement should have an expanded role in the design of safer commercial chemicals, especially since isosteric substitution has the added marketing advantage that it may enable one to circumvent chemicals protected by patents and marketed by competitors. 

Enzymes often prove to be the catalyst of choice for numerous transformations, and their prowess is particularly noteworthy for the synthesis of chiral molecules. The ability of biocatalysts to impart chirality through conversion of prochiral molecules or by transformation of only one stereoisomer of a racemic mixture stems from the inherent chirality of enzymes. As noted in the introduction to this book (Chapter 1), the chiral drug market is increasing, partly as a result of the need to produce single enantiomers as advocated by the U.S. Food and Drag Administration.1 The ability to extend the patent life of a drug through a racemic switch also plays a role in this increase. An example of a racemic switch is Astra Zeneca s Esomeprazole, a proton pump inhibitor (see Chapter 31).2... 

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