Hatch-Waxman: Balancing Innovation and Drug Competition

Learn about the Hatch-Waxman Act and its role in balancing innovation and drug competition.

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Myth vs. Fact: Patent Evergreening

Data shows that there are only a few Orange Book listed patents on new drugs, and on average only 2.5 'secondary' patents per drug.

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Generic Entrants Gain Market Share Quicker and to a Greater Extent Than Ever Before

The time it takes for a generic medicine to come to market has remained steady at approximately 13.5 years for over two decades. And, once entering the market, generics are acquiring greater market share, faster than ever before.

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The U.S. Produces More New Drugs Than the Rest of the World Combined

The U.S. produces more new drugs than the rest of the world combined. In addition, U.S. bioscience firms employ 1.7 million people in communities across the country.

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Generic Share of Total Prescriptions Dispensed in The U.S.

The U.S. leads the world in innovation AND has the most robust generic market in the developed world.

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BIO supports FDA Reform Efforts to Incentivize and Speed Generic Entry

FACT: The U.S. leads the world in innovation AND has the most robust generic market in the developed world.

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Generic Drug Applications Approved by Year

New reforms to incentivize and speed generic and biosimilar entry led to a historic year for generic approvals.

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The Main Challenge for Generic Drug Makers is Poor First-Cycle Approval Rates

The FDA is addressing induvial abuses, but improvement in poor quality of generic applications is key to spurring more competition.

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