Drug Price Competition passage

The pharmaceutical marketplace has also become more crowded as innovative pharmaceutical firms compete with a growing number of generic producers as well as their own products via parallel importation. The passage of the 1984 Drug Price Competition and Patent Term Restoration Act (The Hatch-Waxman Act) intensified... 

Passage of the 1984 Drug Price Competition and Patent Term Restoration Act (Waxman-HatchAct) permits the FDA to use an expedited review process for approval of generic versions of brand-name drugs that have been found to be safe and effective but are no longer protected by a patent.The expedited review process is known as an abbreviated new drug application (ANDA). 

A decline of 20 percent per year in originator revenues from the date of patent loss would mean that within 3 years tier patent expiration, originator sales revenue would be just51 percent of its sales in the year of patent expiration. Fully 6 years after the passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) there is no evidence that the rate of revenue loss for originator compounds is approaching this rate. For the NPV of returns on R D to equal zero, the postpatent decline in revenues would have to be over 30 percent per year from the year of patent expiration. 

Marketing of less-costly generic drugs is expedited with congressional passage of the Dmg Price Competition and Patent Term Restoration Act. Under the new regulations, the FDA could approve applications for... 

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