Tag: drug protection

Patent Exclusivity vs Market Exclusivity: What’s the Real Difference for Drug Prices?

Patent Exclusivity vs Market Exclusivity: What’s the Real Difference for Drug Prices?
Posted by: Alan Burity Vitulo in: Industry Insights
7 Feb | 02:04 AM | 15

Patent exclusivity and market exclusivity are two separate legal tools that protect drug prices. Patents cover inventions; FDA exclusivity blocks generics using clinical data-even without a patent. Understanding the difference explains why some drugs stay expensive long after patents expire.

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Understanding the FDA Pregnancy and Lactation Labeling Rule (PLLR)
Understanding the FDA Pregnancy and Lactation Labeling Rule (PLLR)

Learn how to interpret the FDA's Pregnancy and Lactation Labeling Rule (PLLR), moving from old A-X categories to detailed narrative safety summaries.

Published ON: 7 Apr

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