Tag: market exclusivity

Market Exclusivity Extensions: Mechanisms Beyond Patents Explained

Market Exclusivity Extensions: Mechanisms Beyond Patents Explained

Maddie Shepherd Aug 11 0 Comments

Explore how pharmaceutical companies extend market dominance beyond patent expiration using regulatory exclusivities like PTE, SPCs, and orphan drug protections in the US and EU.

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Pediatric Exclusivity: How the FDA Extends Market Protection for Drugs

Pediatric Exclusivity: How the FDA Extends Market Protection for Drugs

Maddie Shepherd Apr 13 13 Comments

Learn how the FDA uses pediatric exclusivity to extend market protection for drugs by 6 months, incentivizing pediatric research while blocking generic entry.

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