This chart shows the companies which have received the most GAIN Act exclusivities in the past five years.
The Generating Antibiotic Incentives Now Act provides for five years of market exclusivity for qualifying drugs.
The law defines qualifying drugs as ‘an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.’
Unlike most other regulatory extensions, which provide exclusivity starting from a drug’s approval date, GAIN Act exclusivity provides an additional five
years on top of any Hatch-Waxman exclusivity — even pediatric exclusivity, which extends an additional six months beyond patent protection.
The companies with the GAIN Act exclusivities are:
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