There are several types of market exclusivity that may apply to cancer drugs:
New Chemical Entity (NCE) Exclusivity: Granted for drugs containing active ingredients that have never been approved before. Orphan Drug Exclusivity: Applies to drugs developed for rare diseases, including certain types of cancer. Pediatric Exclusivity: An additional six months granted if the sponsor conducts FDA-requested pediatric studies. Patent Term Extensions: Allow extensions of up to five years beyond the original patent expiration date for drugs that undergo lengthy regulatory review.
