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Patent Term and Exclusivity

In what other countries has patent protection been sought?

  • Determine the natural expiration of key patents
  • US patents
  • Ex-US patents
  • Obtain actual or estimated IND and NDA filing dates and estimated NDA approval date
  • Calculate or estimate Hatch-Waxman extension
  • Calculate or estimate marketing exclusivity period in major markets
  • Identify patent that will be subject to Hatch-Waxman extension
  • Determine exclusivity period for competitor products
  • Will competitor become generic before your product?