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How the Hatch-Waxman Act boosted generic drugs, lowered costs

September 10, 2024
in Health
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That is Half 4 of “Behind the Counter,” an in-depth video sequence demystifying the advanced world of patents and drug pricing.

Years in the past, when a brand-name remedy’s patent expired, shoppers needed to wait a very long time for a extra reasonably priced generic model to return to market. However in 1984, a little-known regulation put an finish to that ready interval and paved the best way for the massive amount of generic medication obtainable right now.

The Drug Worth Competitors and Patent Time period Restoration Act of 1984 — also called the “Hatch-Waxman Act” after the 2 legislators who sponsored the invoice — makes it simpler for generic medication to enter the business, together with permitting generic drugmakers to begin analysis and growth on generics previous to the patent expiration of the brand-name drug with out threat of patent infringement. In return, brand-name drugmakers got a patent extension — 5 additional years of market exclusivity on their drug.

However Hatch-Waxman isn’t an ideal regulation. On this video, we clarify how the Hatch-Waxman Act works to increase brand-name drug patent safety and in addition facilitate generic drug market entry, but in addition how it’s restricted in its energy. We additionally cowl different patent extensions which might be used to delay generic drug entry and the methods this could have an effect on shoppers.

STAT’s protection of patent points is supported by a grant from the Commonwealth Fund. Our monetary supporters usually are not concerned in any selections about our journalism.

Behind the Counter

Discover STAT’s video explainer sequence on patents and drug pricing.



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Tags: ActboostedCostsdrugsgenericHatchWaxmanlowered
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