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| Table 2 Total Estimated R & D Expenditures by Major Pharmaceutical Companies | | Year | | Total estimated expenditure ($B) |
| | 1970 | | | 1975 | | | 1980 | | | 1985 | | | 1990 | | | 1993 | | | Source: Ref. [5]. |
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with 3567 in 19891992 while, over the same period, the average number of clinical studies per NDA increased from about 30 to 60 and the number of pages per NDA increased from approximately 45,000 to 90,000 [7]. |
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A further challenge to pharmaceutical companies is the shrinking of the period of marketing exclusivity [8] as indicated in Table 3. The examples shown and the well-known marketing approvals in rapid succession of multiple products in each of the antidepressant, anticholesterol, and antiinfective classifications in recent years emphasize that the competition in drug development is intense. |
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II. Responses to the Challenges |
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These numerous major challenges have stimulated dramatic responses from the industry. Most noticeably perhaps, pharmaceutical companies have taken steps to become as consumer oriented as possible as exemplified by the acquisition |
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| Table 3 Period of Exclusivity Shrinking | | First launch (drug/year) | | Second launch (drug/year) |
| | | Inderal/1968 | Lopressor/1978 | | | Tagamet/1975 | Zantac/1983 | | | Seldane/1984 | Hismanal/1988 | | | Zofran/1991 | Kytril/1992 | | | Source: Ref. [8]. |
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