Tag: FDA exclusivity
Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market
Biologic drugs in the U.S. enjoy 12 years of market exclusivity before biosimilars can enter, thanks to FDA rules and patent thickets. This delays competition, keeps prices high, and leaves patients paying more than those in other countries.
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Regulatory Exclusivity: How Non-Patent Protections Delay Generic Drugs
Regulatory exclusivity is a government-granted market protection that delays generic drug approval, independent of patents. It gives drugmakers 5 to 12 years of exclusive sales rights and plays a major role in high drug prices.
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