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?

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