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Patent Term and Exclusivity
- Determine the natural expiration of key patents
- Identify patent that will be subject to Hatch-Waxman extension
- 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
- Determine exclusivity period for competitor products
- Will competitor become generic before your product?
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