Tag: pediatric exclusivity

Pediatric Exclusivity: How the FDA Extends Market Protection Without Touching Patents

Pediatric Exclusivity: How the FDA Extends Market Protection Without Touching Patents

Pediatric exclusivity gives drugmakers six extra months of market protection after patent expiry by blocking generic approvals-not by extending patents, but by delaying FDA approval of competing drugs. It's a powerful, legally backed tool that affects all forms of a drug with the same active ingredient.

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