The worldwide pharmaceutical industry has
volume greater than
number of individual drugs boasting sales volumes of over
million each. Indeedsome drugs have been called "blockbuster drugs"-those generating at
$300 million innew revenues each year. The profit margins in drug manufacture are higher than the rest
the chemical industry and, of course, research expenditures are huge in order to maintainposition and develop new drugs in this highly competitive industry.The presentday drug industry
one of rapid change.Patents
current best-selling drugs are expiring.
has been estimated that thetop
products in the marketplace will
come off patent (that
expire) in the period between 1973 and 1990.As patents expire, exclusivity of producing
trade-named product will pass andcompetitiveversions of the basic drug will be marketed under generic names
trade names) by new manufacturers.
has been estimated that
the market in 1990 will be generic drugs.New products will come on the market
New products are developed through research.Products now marketed in Europe and Asia attain approved statusby the
Food and Drug Administration (FDA) and enter thehuge and lucrative American market.Information on patented processes offers
number of commercial opportunities:
The patent expiration date (in the
usually 17 years after the patentissuance date cited) offers the opportunity to duplicate and practice thepatented process without
conflict after expiration.
The statement of ownership of the patents affords the opportunity tolicense the patent in question from the patent holder.(3) The definition of the patented process offers the opportunity to an in-novative chemist to develop
process which bypasses the original patentclaims and offers
new legally clear route to an economically attractiveproduct.This encyclopedic work gives details
the manufacture of
pharmaceuticals, nowbeing marketed
trade-named products somewhere in the world. The pertinent processinformation has been obtained from examples given in the pertinent patent literature(usually
patents and sometimes British patents).In addition to the patentderived process information, references are also cited under eachdrug's entry to major pharmaceutical reference works where additional information can beobtained on synthesis methods and the pharmacology of the individual products.