Though the FDA approved a record-breaking number of ANDAs in 2016 and the median time for a brand drug to hold a patent is 12.5 years, drug manufacturers have found ways to extend the life of a patent.3,11 Manufacturers refer to this as product life-cycle management. This involves trying to prevent generic competition and maintain drug exclusivity. Brand-drug manufacturers can achieve this by obtaining additional patents on other aspects of a drug.

Although the generic-drug market has experienced overall stable drug pricing since the enactment of the Hatch-Waxman Act, there have been an increasing number of spikes in generic-drug pricing. These spikes are usually the result of a lack or absence of market competition.


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